Note: This document contains side effect information about factor ix complex. Some dosage forms listed on this page may not apply to the brand name Bebulin VH.
Applies to factor ix complex: intravenous powder for injection.
Warning
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Get emergency medical help if you have signs of an allergic reaction: hives or rash; fast heartbeats; chest tightness, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have:
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sweating and feeling short of breath;
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a light-headed feeling, like you might pass out;
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easy bruising, increased bleeding episodes;
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bleeding from a wound or where the medicine was injected;
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signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
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signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.
Common side effects may include:
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headache;
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flushing (warmth, redness, or tingly feeling);
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nausea, vomiting;
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fever, chills; or
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lack of energy.
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 factor ix complex: intravenous powder for injection.
General
Adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, urticaria, and manifestations of allergic reactions.[Ref]
Cardiovascular
Frequency not reported: Flushing, hypotension
Postmarketing reports: Thrombosis, deep vein thrombosis, tachycardia[Ref]
Immunologic
Frequency not reported: Allergic reaction
Postmarketing reports: Hypersensitivity reaction, inhibitor antibody development, anaphylactic/anaphylactoid reaction[Ref]
Respiratory
Postmarketing reports: Pulmonary embolism, shortness of breath, dyspnea, bronchospasm, wheezing, cough[Ref]
Dermatologic
Frequency not reported: Urticaria, erythema
Postmarketing reports: Diaphoresis, angioedema, rash, pruritus[Ref]
Hematologic
Postmarketing reports: Disseminated intravascular coagulation[Ref]
Nervous system
Frequency not reported: Headache, tingling, lethargy, dizziness
Postmarketing reports: Thrombotic stroke[Ref]
Gastrointestinal
Frequency not reported: Nausea, vomiting
Postmarketing reports: Abdominal pain[Ref]
Other
Frequency not reported: Fever, chills
Postmarketing reports: Facial edema[Ref]
Renal
Postmarketing reports: Nephrotic syndrome (following attempted immune tolerance induction)
Local
Postmarketing reports: Infusion site reactions, infusion site pain
