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Bebulin Side Effects

Generic Name: factor ix complex

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

For the Consumer

Applies to factor ix complex: intravenous solution reconstituted

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of certain infections (parvovirus B19, hepatitis A) like fever or chills, feeling very sleepy, runny nose, rash, joint pain, tiredness, poor appetite, upset stomach or throwing up, belly pain, or yellow skin or eyes.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
  • Shortness of breath.
  • A heartbeat that does not feel normal.
  • Chest pain or pressure or a fast heartbeat.
  • Coughing up blood.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • Cough.
  • Bleeding that is new or worse.
  • A burning, numbness, or tingling feeling that is not normal.
  • Restlessness.
  • Upset stomach or throwing up.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Flushing.
  • Headache.
  • Tingling.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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

References

1. "Product Information. Profilnine SD (Factor IX Complex)." Grifols Biologicals Inc, Los Angeles, CA.

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.

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