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Novoseven Side Effects

Generic Name: coagulation factor viia

Note: This page contains side effects data for the generic drug coagulation factor viia. It is possible that some of the dosage forms included below may not apply to the brand name Novoseven.

For the Consumer

Applies to coagulation factor viia: intravenous powder for solution

As well as its needed effects, coagulation factor viia (the active ingredient contained in Novoseven) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking coagulation factor viia, check with your doctor or nurse immediately:

More common:
  • Bleeding problems
  • fever
  • high blood pressure
  • joint or muscle pain or stiffness
Less common or rare:
  • Bloating or swelling of the face, hands, lower legs, or feet
  • bluish color of the hands or feet
  • blurred vision
  • changes in facial color
  • chest pain
  • chills
  • cold sweats
  • confusion
  • continuing thirst
  • cough
  • dizziness
  • excessive sweating
  • faintness
  • fast heartbeat
  • hives, itching, or skin rash
  • large flat blue or purplish patches on the skin
  • lightheadedness when getting up suddenly from a lying or sitting position
  • persistent bleeding or oozing from puncture sites or mucous membranes (bowel, mouth, nose, or urinary bladder)
  • puffiness or swelling of the eyelids or around the eyes
  • shakiness
  • slow or irregular heartbeat (less than 50 beats per minute)
  • slurred speech
  • sneezing
  • sore throat
  • sudden decrease in the amount of urine
  • swelling of the face, fingers, feet, or lower legs
  • troubled breathing, tightness in the chest
  • unusual tiredness or weakness
  • unusual weight gain

Minor Side Effects

Some coagulation factor viia side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common or rare:
  • Burning or stinging at the injection site
  • drowsiness
  • feeling of warmth
  • headache
  • nausea or vomiting
  • pinpoint red or purple spots on the skin
  • redness of the face, neck, arms and occasionally, upper chest

For Healthcare Professionals

Applies to coagulation factor viia: 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]


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

Common (1% to 10%): Antibody formation against this drug
Rare (less than 0.1%): Hypersensitivity
Postmarketing reports: Anaphylactic reaction[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)" Novo Nordisk Pharmaceuticals, Princeton, NJ.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

It is possible that some side effects of Novoseven may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.