FDA label

What is hydroxyurea used for?

The FDA-approved uses of hydroxyurea, 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: “Hydroxyurea capsules are indicated for the treatment of: Resistant chronic myeloid leukemia; Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation.”

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Hydroxyurea, capsule

Indications and Usage, quoted from the label by Par Health USA, LLC (ANDA075340). Cross-references to other label sections are left out.

Hydroxyurea capsules are indicated for the treatment of:

  • Resistant chronic myeloid leukemia.
  • Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation.

Source: DailyMed label, set id 9e1bdd4b-043a-4cf6-b1ff-8de49e02b7a6, version 23, effective May 7, 2026. NDC 49884-724, one of 10 listings for this product.

Questions

What is hydroxyurea used for?

The FDA label says: “Hydroxyurea capsules are indicated for the treatment of: Resistant chronic myeloid leukemia; Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation.”

What drug class is hydroxyurea?

FDA lists hydroxyurea in the Antimetabolite 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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