Novoseven Side Effects

Generic name: coagulation factor viia

Note: This document contains side effect information about coagulation factor viia. Some of the dosage forms listed on this page may not apply to the brand name Novoseven.

Some side effects of Novoseven may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to coagulation factor viia: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking coagulation factor viia (the active ingredient contained in Novoseven) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• fever;

• little or no urinating;

• a feeling that you might pass out; or

• any bleeding that will not stop.

Common side effects may include:

• mild headache;

• joint pain;

• nausea, vomiting;

• swelling;

• mild itching or rash; or

• pain, redness, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to coagulation factor viia: intravenous powder for injection

Hematologic

Hematologic side effects have included hemorrhage, decreased plasma fibrogen, coagulation disorders, increased fibrinolysis, decreased prothrombin, disseminated intravascular coagulation, thrombophlebitis, arterial thrombosis, and deep vein thrombosis.

Cardiovascular

Cardiovascular side effects have included edema, hypertension, hypotension, myocardial infarction, angina pectoris, and bradycardia.

General

General side effects have included pain and fever.

Nervous system

Nervous system side effects have included headache, intracranial hemorrhage, cerebral infarction, cerebral ischemia, and subdural hematoma.

Hypersensitivity

Hypersensitivity side effects have included isolated cases of hypersensitivity reactions including anaphylactic reactions.

Respiratory

Respiratory side effects have included pulmonary embolism and pneumonia.

Local

Local side effects have included injection site reaction.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.

Dermatologic

Dermatologic side effects have included rash, pruritus, and purpura.

Musculoskeletal

Musculoskeletal side effects have included arthralgia and hemarthrosis.

Renal

Renal side effects have included abnormal renal function.

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