Hydroxyurea is an antimetabolite indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises. MedsAcross supplies Hydroxyurea for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises. DROXIA is an antimetabolite indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises.
Source: US FDA prescribing information
The precise mechanism by which hydroxyurea produces its cytotoxic and cytoreductive effects is not known. However, various studies support the hypothesis that hydroxyurea causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or of protein. The mechanisms by which DROXIA produces its beneficial effects in patients with sickle cell anemia (SCA) are uncertain. Known pharmacologic effects of DROXIA that may contribute to its beneficial effects include increasing hemoglobin F levels in red blood cells (RBCs), decreasing neutrophils, increasing the water content of RBCs, increasing deformability of sickled cells, and altering the adhesion of RBCs to endothelium.
Source: US FDA prescribing information
Initial dose: 15 mg/kg once daily. Monitor the patient's blood count every two weeks. 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. 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. Renal impairment: Reduce the dose of DROXIA by 50% in patients with creatinine clearance less than 60 mL/min.
Source: US FDA prescribing information
DROXIA is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. • In patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation.
Source: US FDA prescribing information
Boxed warning (myelosuppression and malignancies): Myelosuppression: DROXIA may cause severe myelosuppression. Do not give if bone marrow function is markedly depressed. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary. Malignancies: DROXIA is carcinogenic. Advise sun protection and monitor patients for malignancies. Hemolytic anemia: Monitor blood counts throughout treatment. If hemolysis persists, discontinue DROXIA. Embryo-Fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. Vasculitic toxicities: Institute treatment and discontinue DROXIA if this occurs. Live Vaccinations: Avoid live vaccine use in a patient taking DROXIA. Risks with concomitant use of antiretroviral drugs: Pancreatitis, hepatotoxicity, and neuropathy have occurred.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described in detail in other labeling sections: Myelosuppression Hemolytic anemia Malignancies Vasculitic toxicities Risks with concomitant use of antiretroviral drugs Macrocytosis Pulmonary Toxicity 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.
Source: US FDA prescribing information
Antiretroviral drugs. Laboratory Test Interference. 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.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
10 presentations of Hydroxyurea, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Hydroxyurea 500 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Droxia 200 mg capsuleOral | Waylis Therapeutics | US FDA | Available on request |
| Droxia 300 mg capsuleOral | Waylis Therapeutics | US FDA | Available on request |
| Droxia 400 mg capsuleOral | Waylis Therapeutics | US FDA | Available on request |
| Hydrea 500 mg capsuleOral | Waylis Therapeutics | US FDA | Available on request |
| Hydroxyurea 100 mg tabletOralGeneric name | — | US FDA | Available on request |
| Hydroxyurea 1000 mg tabletOralGeneric name | — | US FDA | Available on request |
| Siklos 100 mg tabletOral | Medunik | US FDA | Available on request |
| Siklos 1000 mg tabletOral | Medunik | US FDA | Available on request |
| Xromi 100 mg/mL oral solutionOral Cold chain | Nova Laboratories | US FDA | Available on request |
4 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Hydroxyurea in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 10 presentations of Hydroxyurea and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 4 brand names for Hydroxyurea, including Droxia, Hydrea, Siklos, Xromi.
Yes. The US FDA first approved Hydroxyurea on 7 December 1967, according to Drugs@FDA.
Yes. Hydroxyurea has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Hydroxyurea must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Hydroxyurea is classified under ATC code L01XX05 (Hydroxyurea).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.