Arixtra Side Effects

Generic name: fondaparinux

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

Some side effects of Arixtra 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 fondaparinux: subcutaneous solution

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

Stop using fondaparinux and call your doctor at once if you have a serious side effect such as:

• unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle injections, any bleeding that will not stop;

• easy bruising, purple or red pinpoint spots under your skin;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• black or bloody stools, coughing up blood or vomit that looks like coffee grounds;

• numbness, tingling, or muscle weakness (especially in your legs and feet);

• loss of movement in any part of your body;

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

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, limp feeling).

Less serious side effects of fondaparinux may include:

• sleep problems (insomnia);

• mild skin rash;

• dizziness; or

• minor bleeding, rash, or itching 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 fondaparinux: subcutaneous solution

Hematologic

Hematologic side effects associated with the administration of fondaparinux (the active ingredient contained in Arixtra) 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 (the active ingredient contained in Arixtra) have included elevated aminotransferase levels.

Local

Local side effects associated with the administration of fondaparinux (the active ingredient contained in Arixtra) have included injection site bleeding, rash, and pruritus.

Gastrointestinal

Gastrointestinal side effects associated with the administration of fondaparinux (the active ingredient contained in Arixtra) have included nausea, vomiting, constipation, diarrhea, and dyspepsia.

Nervous system

Nervous system side effects associated with the administration of fondaparinux (the active ingredient contained in Arixtra) have included insomnia, dizziness, and confusion.

Dermatologic

Dermatologic side effects associated with the administration of fondaparinux (the active ingredient contained in Arixtra) have included rash, increased wound drainage, and bullous eruption.

Cardiovascular

Cardiovascular side effects associated with the administration of fondaparinux (the active ingredient contained in Arixtra) have included hypotension and edema.

Genitourinary

Genitourinary side effects associated with the administration of fondaparinux (the active ingredient contained in Arixtra) have included urinary tract infection and urinary retention.

Metabolic

Metabolic side effects associated with the administration of fondaparinux (the active ingredient contained in Arixtra) have included hypokalemia.

Other

Other side effects associated with the administration of fondaparinux (the active ingredient contained in Arixtra) have included fever, headache, and pain.

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