FDA label

What is deferasirox used for?

The FDA-approved uses of deferasirox, 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 deferasirox (tablet, for suspension) lists 2 uses: Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload); Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes.

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Deferasirox, tablet, for suspension

Indications and Usage, quoted from the label by Teva Pharmaceuticals, Inc. (ANDA207124). Cross-references to other label sections are left out.

Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)

Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes

Deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L.

Limitations of Use

The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established.

Source: DailyMed label, set id e9054806-2721-4736-9aef-81ffb8db75d1, version 8, effective July 1, 2024. NDC 0480-7011, one of 30 listings for this product.

Deferasirox, tablet, film coated

Indications and Usage, quoted from the label by Camber Pharmaceuticals, Inc. (ANDA214341). Cross-references to other label sections are left out.

Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)

Deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes

Deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L.

Limitations of Use

The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established.

Source: DailyMed label, set id 65453013-c360-4835-8358-2a278a4a32db, version 3, effective February 11, 2025. NDC 31722-011, one of 27 listings for this product.

Deferasirox, granule

Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA215137). Cross-references to other label sections are left out.

Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)

Deferasirox oral granules are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.

Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes

Deferasirox oral granules are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L.

Limitations of Use

The safety and efficacy of deferasirox oral granules when administered with other iron chelation therapy have not been established.

Source: DailyMed label, set id c220484e-1e6a-4a0c-a221-60223f3bc24c, version 1, effective September 9, 2025. NDC 59651-447, one of 18 listings for this product.

Questions

What is deferasirox used for?

The FDA label for deferasirox (tablet, for suspension) lists 2 uses: Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload); Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes.

What drug class is deferasirox?

FDA lists deferasirox in the Iron Chelator 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.

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