Coagulation factor IX Side Effects

Brand Names: AlphaNine SD, Alphanine SD, BeneFIX, BeneFix, Benefix, Mononine

Please note - some side effects for Coagulation factor IX may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Coagulation factor IX - for the Consumer

Coagulation Factor IX Injection (Recombinant)

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Coagulation Factor IX Injection (Recombinant):

Mild chills; nausea; stinging at the injection site.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; faintness; fever; flushing; headache; lethargy; lightheadedness, especially upon standing; nausea; rapid heart rate; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Coagulation Factor IX Injection (Human)

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Coagulation Factor IX Injection (Human):

Mild chills; nausea; stinging at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; chills; dark urine; faintness; fast or irregular heartbeat; fever; lightheadedness, especially upon standing; loss of appetite; pain, swelling, or tenderness in the calf; severe or persistent dizziness; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; unusual bruising or bleeding; unusual tiredness; wheezing; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity reactions, including bronchospastic reactions and/or hypotension and anaphylaxis.

Hematologic

Hematologic side effects have included and the development of high-titer inhibitors necessitating alternative treatments to factor IX replacement therapy.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.

Dermatologic

Dermatologic side effects have included hives, rash, and flushing.

Local

Local side effects have included Injection site reaction, Injection site pain, cellulitis at IV site, and phlebitis at IV site.

Nervous system

Nervous system side effects have included headache, dizziness, taste perversion (altered taste), shaking, and drowsiness.

Respiratory

Respiratory side effects have included dry cough, hypoxia, chest tightness, and dyspnea (respiratory distress)

General

General side effects have included fever.

Ocular

Ocular side effects have included blurred vision.

Renal

Renal side effects have e included renal infarction.

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