Hydroxyurea Brand names: Droxia, Hydrea, Siklos, Xromi

What is hydroxyurea used for?

From the label: indications and usage

HYDREA is 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. HYDREA is an antimetabolite indicated for the treatment of: Resistant chronic myeloid leukemia. ( 1 ) Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation.

Conditions named in the indications of hydroxyurea's FDA labels, with every medicine labeled for each:

• Leukemia, lymphoma and myeloma

FDA pharmacologic class: Antimetabolite.

What does the patient leaflet for hydroxyurea say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about DROXIA?

DROXIA can cause serious side effects including: Low blood counts are common with DROXIA, including low red blood cells, white blood cells, and platelets, and can be severe and life-threatening. If your white blood cell count becomes very low, you are at increased risk for infection. Your healthcare provider will check your blood cell counts before and during treatment with DROXIA. Your healthcare provider may change your dose or tell you to stop taking DROXIA if you have low blood cell counts. Tell your healthcare provider right away if you get any of the following symptoms: fever chills body aches feeling very tired shortness of breath bleeding or unexplained bruising Cancer. Some people have developed cancer, such as leukemia and skin cancer, after taking DROXIA for a long time. Your healthcare provider will check you for cancer. You should protect your skin from the sun using sunblock, hats, and sun-protective clothing. DROXIA can harm your unborn baby. For females taking DROXIA who can become pregnant: You should talk with your healthcare provider about the risks of DROXIA to your unborn baby. You should use effective birth control during treatment with DROXIA and for at least 6 months after treatment. Your healthcare provider will perform a pregnancy test before you start treatment with DROXIA. You should avoid becoming pregnant during treatment with DROXIA. Tell your healthcare provider right away if you become pregnant or think you may be pregnant. For males taking DROXIA: DROXIA can affect your sperm. If you have a female sexual partner who can become pregnant, you should use a condom during treatment with DROXIA and for at least 1 year after treatment. DROXIA may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you. […]

From the patient leaflet: How should I store DROXIA?

Store DROXIA at room temperature between 68°F to 77°F (20°C to 25°C). Keep the DROXIA bottle tightly closed. Call your healthcare provider for instructions on how to throw away (dispose of) DROXIA that is out of date. Keep DROXIA and all medicines out of the reach of children. Keep DROXIA away from pets.

Is there a generic for hydroxyurea (Hydrea)?

The FDA approved the first generic hydroxyurea on August 18, 1995. 7 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists hydroxyurea from 10 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists no patent for Hydrea capsules; a patent listed only for Xromi oral solution runs to December 23, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

What do pharmacies pay for hydroxyurea (Hydrea)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.184 per Hydroxyurea 500 mg capsule, down 8% from $0.199 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Has hydroxyurea been recalled?

The FDA's Enforcement Report lists 1 recall naming hydroxyurea since 2015: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of hydroxyurea and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

What does the hydroxyurea label say about other medicines?

The hydroxyurea label names no other medicine on this site. The labels of 16 other medicines name hydroxyurea. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Other labels that name hydroxyurea

• Ganciclovir
• Ivosidenib
• Olutasidenib
• Valganciclovir

Check hydroxyurea against other medicines

What do FAERS reports show for hydroxyurea?

The FDA Adverse Event Reporting System holds 21,023 reports that list hydroxyurea among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,145 are coded as a death and 7,991 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

• 1,222
• 1,357
• 1,678
• 1,470
• 1,735
• 1,878
• 1,933
• 1,730
• 1,387
• 1,260
• 560

• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

The most reported reactions

• Off Label Use (a use or a product term, not a reaction)2,188
• Fatigue1,547
• Sickle Cell Anaemia With Crisis1,485
• Diarrhoea (named in the label)1,407
• Nausea (named in the label)1,304
• Headache (named in the label)1,068
• Anaemia (named in the label)1,045
• Death (an outcome recorded in the report)1,042

Side effects: the label's list and every FAERS reaction

What else is labeled for the same conditions as hydroxyurea?

37 other medicines are given the same way (oral) and in the same FDA class as hydroxyurea or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Every medicine labeled for the same conditions as hydroxyurea

What next?

Alternatives to hydroxyurea

37 medicines for the same use

Other antimetabolites

the pharmacologic class, with prices and generics

Hydroxyurea side effects

the label's list beside FAERS reports

Check an interaction

what two or more labels say about each other