FDA label
What is fondaparinux used for?
The FDA-approved uses of fondaparinux, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for fondaparinux sodium (injection, solution) lists 3 uses: Prophylaxis of Deep Vein Thrombosis; Treatment of Acute Deep Vein Thrombosis; Treatment of Acute Pulmonary Embolism.
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Fondaparinux Sodium, injection, solution
Indications and Usage, quoted from the label by Zydus Pharmaceuticals (USA) Inc. (ANDA208615). Cross-references to other label sections are left out.
Prophylaxis of Deep Vein Thrombosis
Fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
- in patients undergoing hip fracture surgery, including extended prophylaxis;
- in patients undergoing hip replacement surgery;
- in patients undergoing knee replacement surgery;
- in patients undergoing abdominal surgery who are at risk for thromboembolic complications.
Treatment of Acute Deep Vein Thrombosis
Fondaparinux sodium injection is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.
Treatment of Acute Pulmonary Embolism
Fondaparinux sodium injection is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.
Source: DailyMed label, set id dffbf7c9-495e-4a33-ac76-57b52f014fc2, version 20, effective October 28, 2025. NDC 70710-1514, one of 12 listings for this product.
Fondaparinux Sodium, injection
Indications and Usage, quoted from the label by Sandoz Inc. (ANDA206812). Cross-references to other label sections are left out.
Prophylaxis of Deep Vein Thrombosis in Adult Patients
Fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT in adults), which may lead to pulmonary embolism (PE):
- in patients undergoing hip fracture surgery, including extended prophylaxis;
- in patients undergoing hip replacement surgery;
- in patients undergoing knee replacement surgery;
- in patients undergoing abdominal surgery who are at risk for thromboembolic complications.
Treatment of Acute Deep Vein Thrombosis in Adult Patients
Fondaparinux sodium injection is indicated for the treatment of acute deep vein thrombosis in adults when administered in conjunction with warfarin sodium.
Treatment of Acute Pulmonary Embolism in Adult Patients
Fondaparinux sodium injection is indicated for the treatment of acute pulmonary embolism in adults when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.
Treatment of Venous Thromboembolism in Pediatric Patients
Fondaparinux sodium injection is indicated for the treatment of venous thromboembolism (VTE) in pediatric patients aged 1 year or older weighing at least 10 kg.
Source: DailyMed label, set id baa50757-a927-4d56-a933-5d7798fe6ab0, version 18, effective August 27, 2025. NDC 0781-3443, one of 8 listings for this product.
Questions
What is fondaparinux used for?
The FDA label for fondaparinux sodium (injection, solution) lists 3 uses: Prophylaxis of Deep Vein Thrombosis; Treatment of Acute Deep Vein Thrombosis; Treatment of Acute Pulmonary Embolism.
What drug class is fondaparinux?
FDA lists fondaparinux in the Factor Xa Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.