Arixtra Side Effects

Please note - some side effects for Arixtra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Arixtra - for the Consumer

Arixtra

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 Arixtra:

Bleeding, irritation, rash, or itching at the injection site; chills; constipation; diarrhea; headache; minor bleeding; nausea; sleeplessness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; confusion; fever; one-sided weakness; persistent headache; slurred speech; swelling of the ankles, feet, or hands; unusual dizziness, tiredness, or weakness; unusual or severe bleeding or bruising; vision changes.

Arixtra Side Effects - for the Professional

Arixtra

The most common adverse reactions associated with the use of Arixtra are bleeding complications. (6.1) Mild local irritation (injection site bleeding, rash, and pruritus) may occur following subcutaneous injection. (6.2)

Anemia, insomnia, increased wound drainage, hypokalemia, dizziness, hypotension, confusion, bullous eruption, hematoma, post-operative hemorrhage, and purpura may occur. (6.4)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System

Hematologic

Hematologic side effects associated with the administration of fondaparinux have included major bleeding, anemia, purpura, thrombocytopenia, postoperative hemorrhage and hematoma. Occurrences of major bleeding in patients receiving therapeutic regimen in treatment of DVT and PE with normal renal function, mild renal impairment, moderate renal impairment, and severe renal impairment have been found to be 0.4%, 1.6%, 2.2%, and 7.3%, respectively. Moderate thrombocytopenia occurred at a rate of 0.5% in patients given fondaparinux treatment regimen in the DVT and PE treatment clinical trials. Severe thrombocytopenia occurred at a rate of 0.04% in patients given fondaparinux treatment regimen in the DVT and PE treatment clinical trials.

Rare cases of elevated aPTT and heparin-induced thrombocytopenia have been reported. A causal relationship of these events to fondaparinux has not been established.

Hepatic

Hepatic side effects associated with the administration of fondaparinux have included elevated aminotransferase levels.

Local

Local side effects associated with the administration of fondaparinux have included injection site bleeding, rash, and pruritus.

Gastrointestinal

Gastrointestinal side effects associated with the administration of fondaparinux have included nausea, vomiting, constipation, diarrhea, and dyspepsia.

Nervous system

Nervous system side effects associated with the administration of fondaparinux have included insomnia, dizziness, and confusion.

Dermatologic

Dermatologic side effects associated with the administration of fondaparinux have included rash, increased wound drainage, and bullous eruption.

Cardiovascular

Cardiovascular side effects associated with the administration of fondaparinux have included hypotension and edema.

Genitourinary

Genitourinary side effects associated with the administration of fondaparinux have included urinary tract infection and urinary retention.

Metabolic

Metabolic side effects associated with the administration of fondaparinux have included hypokalemia.

Other

Other side effects associated with the administration of fondaparinux have included fever, headache, and pain.

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