Skip to main content

Coagulation factor viia Side Effects

Medically reviewed by Last updated on May 26, 2023.

Applies to coagulation factor viia: intravenous powder for solution.


Intravenous route (Powder for Solution)

Serious arterial and venous thrombotic events are associated with the use of coagulation factor VIIa. Patients should be advised of the risks and know the signs and symptoms of thrombotic and thromboembolic events. Monitor for signs/symptoms of thrombosis and of activation of the coagulation cascade.

Intravenous route (Powder for Solution)

ThrombosisSerious arterial and venous thrombotic events may occur following administration of coagulation factor VIIa recombinant-jncw.Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive coagulation factor VIIa (recombinant)-jncw.Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.

Serious side effects

Along with its needed effects, coagulation factor viia 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 coagulation factor viia:

More common

Less common or rare

Other side effects

Some side effects of coagulation factor viia 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:

Less common or rare

For Healthcare Professionals

Applies to coagulation factor viia: intravenous injection, intravenous powder for injection.


The most common adverse reactions were thrombotic events.[Ref]


Common (1% to 10%): Hypertension, thromboembolic events

Uncommon (0.1% to 1%): Shock

Rare (less than 0.1%): Angina pectoris

Postmarketing reports: Intracardiac thrombus, flushing[Ref]

Specific arterial thromboembolic events (cerebral artery occlusion, cerebrovascular accident), specific venous thromboembolic events (pulmonary embolism, deep vein thrombosis), and angina pectoris were reported with a frequency of common (1% to 10%) in clinical trials of 61 patients with acquired hemophilia.[Ref]


Common (1% to 10%): Plasma fibrinogen decreased, acute post-operative hemarthrosis

Rare (less than 0.1%): Disseminated intravascular coagulation, D dimer increased, antithrombin decreased, coagulopathy, fibrin degradation products increased, alkaline phosphatase increased, lactate dehydrogenase increased, prothrombin increased[Ref]


Common (1% to 10%): Antibody formation against this drug

Rare (less than 0.1%): Hypersensitivity

Postmarketing reports: Anaphylactic reaction[Ref]

Antibody formation against this drug has only been reported in patients with factor VII deficiency.[Ref]

Nervous system

Common (1% to 10%): Intracranial hypertension, headache

Uncommon (0.1% to 1%): Cerebrovascular accident

Frequency not reported: Cerebrovascular disorder[Ref]


Common (1% to 10%): Localized phlebitis

Rare (less than 0.1%): Injection site reaction[Ref]


Common (1% to 10%): Fever

Frequency not reported: Pain[Ref]


Uncommon (0.1% to 1%): Rash, pruritus, urticaria

Postmarketing reports: Angioedema[Ref]


Uncommon (0.1% to 1%): Nausea[Ref]


Uncommon (0.1% to 1%): Dyspnea[Ref]


Rare (less than 0.1%): Alanine aminotransferase increased

Frequency not reported: Abnormal hepatic function[Ref]


1. Product Information. NovoSeven (coagulation factor VIIa). Apothecon Inc. 2022.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

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.