FDA label
What is warfarin used for?
The FDA-approved uses of warfarin, 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 says: “JANTOVEN ®is indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE); Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement; Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myo...”
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Warfarin Sodium, tablet
Indications and Usage, quoted from the label by Upsher-Smith Laboratories, LLC (ANDA040416). Cross-references to other label sections are left out.
JANTOVEN ®is indicated for:
- Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
- Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
- Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Limitations of Use
Warfarin Sodium has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
Source: DailyMed label, set id 19a69a72-ac5d-45d5-a94d-a5aaecbe4730, version 13, effective July 8, 2025. NDC 0832-1211, one of 149 listings for this product.
Questions
What is warfarin used for?
The FDA label says: “JANTOVEN ®is indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE); Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement; Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myo...”
What drug class is warfarin?
FDA lists warfarin in the Vitamin K Antagonist 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.
More on Warfarin
- Is Warfarin a controlled substance?Federal schedule
- Generic for CoumadinFDA Orange Book
- Generic for AthrombinFDA Orange Book
- Generic for PanwarfinFDA Orange Book
- What is Jantoven used for?FDA label uses
- Is Jantoven a controlled substance?Federal schedule
- Vitamin K Antagonists listFDA drug class
- NDC 0093-1712Warfarin NDC record
- NDC 0093-1713Warfarin NDC record
- NDC 0093-1714Warfarin NDC record