DROXIA ® (hydroxyurea capsules, USP) is available for oral use as capsules containing 200 mg, 300 mg, and 400 mg hydroxyurea. Inactive ingredients include citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide, and capsule colorants: FD&C Blue No. 1 and FD&C Green No. 3 (200 mg capsules); D&C Red No. 28, D&C Red No. 33, and FD&C Blue No. 1 (300 mg capsules); D&C Red No. 28, D&C Red No. 33, and D&C Yellow No. 10 (400 mg capsules). Hydroxyurea is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. The empirical formula is CH 4 N 2 O 2 and it has a molecular weight of 76.05. Its structural formula is: Hydroxyurea Chemical Structure

What kind of drug is hydroxyurea?

The FDA classifies hydroxyurea as an antimetabolite. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take hydroxyurea with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run hydroxyurea against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is hydroxyurea sold under?

We track 4 hydroxyurea-containing products in the U.S.: Droxia, Hydrea, Siklos and Xromi. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does hydroxyurea come in?

Across the brands we track, hydroxyurea is currently marketed as capsule, tablet and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic hydroxyurea?

We do not currently list a generic-labelled hydroxyurea product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Hydroxyurea: uses, dosing, side effects & brands

Hydroxyurea is an antimetabolite sold in the U.S. under 4 brand and generic names, for brain neoplasms, non-small-cell lung carcinoma and renal cell carcinoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesHow we research

Key facts

Drug class: Antimetabolite
Treats: Brain Neoplasms, Non-Small-Cell Lung Carcinoma and Renal Cell Carcinoma
Available as: Capsule · Tablet · Solution
Sold as: 4 products — Droxia, Hydrea and Siklos, and others
Prescription?: Prescription only
Generic available?: Not in our catalog
Typical price: about $6 for a 30-count supply
Boxed warning: Boxed warning

How hydroxyurea is dosed

From the FDA label for Droxia (application NDA016295). Other hydroxyurea products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Initial dose: 15 mg/kg once daily. Monitor the patient's blood count every two weeks. (2.1) The dose may be increased by 5 mg/kg/day every 12 weeks until a maximum tolerated dose or 35 mg/kg/day is reached if blood counts are in an acceptable range. (2.1) The dose is not increased if blood counts are between the acceptable range and toxic. Discontinue DROXIA until hematologic recovery if blood counts are considered toxic. Treatment may then be resumed after reducing the dose by 2.5 mg/kg/day from the dose associated with hematological toxicity. (2.1) Renal impairment: Reduce the dose of DROXIA by 50% in patients with creatinine clearance less than 60 mL/min. (2.2 , 8.6 , 12.3) 2.1 Dosing Information Table 1: Dosing Recommendation Based on Blood Count Dosing Regimen Dose Dose Modification Criteria Monitoring Parameters Initial Recommended Dosing 15 mg/kg/day as a single dose once daily based on the patient's actual or ideal weight, whichever is less. Monitor the patient's blood count every 2 weeks [see Warnings and Precautions ( 5.1 )]. Dosing Based on Blood Counts In an acceptable range Increase dose 5 mg/kg/day every 12 weeks Maximal dose: 35 mg/kg/day* *Maximal dose is the highest dose that does not produce toxic blood counts over 24 consecutive weeks. Increase dosing only if blood counts are in an acceptable range. Do not increase if myelosuppression occurs. Blood Counts…

Hydroxyurea side effects

The following clinically significant adverse reactions are described in detail in other labeling sections: Myelosuppression [see Warnings and Precautions (5.1) ] Hemolytic anemia [see Warnings and Precautions (5.2) ] Malignancies [see Warnings and Precautions (5.3) ] Vasculitic toxicities [see Warnings and Precautions (5.5) ] Risks with concomitant use of antiretroviral drugs [ see Warnings and Precautions (5.7) ] Macrocytosis [ see Warnings and Precautions (5.8) ] Pulmonary Toxicity [see Warnings and Precautions (5.9) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reactions (≥30%) are hematological, gastrointestinal symptoms, and anorexia. (6) To report SUSPECTED ADVERSE REACTIONS, contact CHEPLAPHARM Arzneimittel GmbH at 1-888-877-5884 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience In 299 patients treated for sickle cell anemia in the Multicenter Study of Hydroxyurea in Sickle Cell Anemia, the most common adverse reactions were hematologic, with neutropenia, and low reticulocyte and platelet levels necessitating temporary cessation in almost all patients. Hematologic recovery usually occurred in two weeks.…

Every hydroxyurea product we track (4)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Hydroxyurea products
#	Drug	Rating	Type	Form	Generic?	Typical price
1	Droxia Boxed warning	Not yet rated	Prescription	Capsule	Generic	$6	View →
2	Hydrea

What hydroxyurea pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Hydroxyurea pill imprints
Imprint	Strength	Colour	Shape	Maker
724;par	500 mg	green, pink	capsule	—
724;par	500 mg	green, pink	capsule	—
SCM	100 mg	white	round	—
SC;SC	500 mg	white	oval	—
724;par	500 mg	green, pink	capsule	—

Frequently asked questions

What is hydroxyurea?: DROXIA ® (hydroxyurea capsules, USP) is available for oral use as capsules containing 200 mg, 300 mg, and 400 mg hydroxyurea. Inactive ingredients include citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide, and capsule colorants: FD&C Blue No. 1 and FD&C Green No. 3 (200 mg capsules); D&C Red No. 28, D&C Red No. 33, and FD&C Blue No. 1 (300 mg capsules); D&C Red No. 28, D&C Red No. 33, and D&C Yellow No. 10 (400 mg capsules). Hydroxyurea is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. The empirical formula is CH 4 N 2 O 2 and it has a molecular weight of 76.05. Its structural formula is: Hydroxyurea Chemical Structure
What kind of drug is hydroxyurea?: The FDA classifies hydroxyurea as an antimetabolite. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take hydroxyurea with other medicines?: It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run hydroxyurea against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is hydroxyurea sold under?: We track 4 hydroxyurea-containing products in the U.S.: Droxia, Hydrea, Siklos and Xromi. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does hydroxyurea come in?: Across the brands we track, hydroxyurea is currently marketed as capsule, tablet and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Hydroxyurea drug interactions

Antiretroviral drugs. (7.1) Laboratory Test Interference. ( 7.2 ) 7.1 Increased Toxicity with Concomitant Use of Antiretroviral Drugs Pancreatitis In patients with HIV infection during therapy with hydroxyurea and didanosine, with or without stavudine , fatal and nonfatal pancreatitis have occurred. Hydroxyurea is not indicated for the treatment of HIV infection; however, if patients with HIV infection are treated with hydroxyurea, and in particular, in combination with didanosine and/or stavudine, close monitoring for signs and symptoms of pancreatitis is recommended. Permanently discontinue therapy with DROXIA in patients who develop signs and symptoms of pancreatitis. Hepatotoxicity Hepatotoxicity and hepatic failure resulting in death have been reported during postmarketing surveillance in patients with HIV infection treated with hydroxyurea and other antiretroviral drugs. Fatal hepatic events were reported most often in patients treated with the combination of hydroxyurea, didanosine, and stavudine. Avoid this combination. Peripheral Neuropathy Peripheral neuropathy, which was severe in some cases, has been reported in patients with HIV infection receiving hydroxyurea in combination with antiretroviral drugs, including didanosine, with or without stavudine. 7.2 Laboratory Test Interference Interference with Uric Acid, Urea, or Lactic Acid Assays Studies have shown that…