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Hydroxyurea

Published: July 26, 2026Updated: August 24, 2026

Hydroxyurea is an antimetabolite chemotherapy agent used primarily to treat certain cancers, sickle cell disease, and other blood disorders. It works by inhibiting DNA synthesis in rapidly dividing cells, which helps control the proliferation of abnormal cells. This medication requires regular blood monitoring due to its effects on bone marrow and is typically prescribed by specialists in oncology or hematology.

Quick summary

Hydroxyurea is a chemotherapy agent that treats certain cancers and blood disorders by inhibiting DNA synthesis in rapidly dividing cells.

Medically reviewed by WellAlly Editorial TeamLast reviewed August 24, 2026Editorial policy

Key facts at a glance

ATC
L01XX05
RxNorm
5552
Generic
Hydroxyurea
Class
atc-l01
Brands
Hydrea, Siklos, Droxia, Xromi
Availability
rx
Lactation
unknown
Routes
oral
Forms
tablet, solution, capsule
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose exceeding 10 grams may cause serious toxicity and potentially fatal outcomes
Chronic overdose: cumulative doses leading to bone marrow suppression and hematologic toxicity
Immediate actions
gastric lavage within 1-2 hours if large dose ingested, activated charcoal, supportive care including fluid replacement and blood product transfusions as needed
Antidote
no specific antidote available(treatment is supportive and symptomatic; early intervention improves outcomes)
Poison Control: 1-800-222-1222

Special Populations

8 groups
✗

pregnancy

first trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks; discuss contraception

Monitor

regular fetal monitoring and ultrasound assessments

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

second trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use unless benefits significantly outweigh risks

Monitor

regular fetal growth monitoring

Use of this medication in this population requires careful consideration of risks and benefits.

✗

pregnancy

third trimester
unsafe
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

discontinue before delivery if possible; consider timing of administration

Monitor

fetal monitoring and assessment of fetal well-being

Use of this medication in this population requires careful consideration of risks and benefits.

✗

lactation

breastfeeding
contraindicated
FDA Category
N
Dose Adjustment

not applicable

Key Recommendations

do not breastfeed during treatment and for at least 1 week after last dose

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

pediatric_age

children
caution
FDA Category
N
Dose Adjustment

weight-based dosing required

Key Recommendations

use under close pediatric supervision; typically 20-30 mg/kg once daily for sickle cell disease

Monitor

regular CBC monitoring, growth and developmental assessment

Use with caution and monitor for adverse effects.

⚠

geriatric

elderly
caution
FDA Category
N
Dose Adjustment

start at lower end of dosing range

Key Recommendations

assess renal and hepatic function before initiating; consider comorbidities

Monitor

regular CBC, renal function and hepatic function monitoring

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe
caution
FDA Category
N
Dose Adjustment

reduce dose by 50% in CrCl <60 mL/min

Key Recommendations

use with caution; monitor renal function regularly; adjust dose based on creatinine clearance

Monitor

frequent CBC and renal function monitoring

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

moderate to severe
caution
FDA Category
N
Dose Adjustment

consider dose reduction

Key Recommendations

use with caution; monitor liver function tests

Monitor

regular CBC and hepatic function monitoring

Use with caution and monitor for adverse effects.

Statistics and clinical data

drug_classWHO
2023

Drug class

Value:Antimetabolite

Hydroxyurea is classified as an antimetabolite and ribonucleotide reductase inhibitor

usageFDA
2023

Primary indications

Value:Sickle cell disease, chronic myelogenous leukemia, polycythemia vera, essential thrombocythemia

Main therapeutic uses of Hydroxyurea

mechanismNIH
2023

Mechanism of action

Value:Ribonucleotide reductase inhibitor

Primary pharmacological mechanism

prescribingFDA
2023

FDA approval year

Value:1970s

Initial FDA approval for cancer indications

Hydroxyurea is used to treat chronic myelogenous leukemia, squamous cell carcinomas of the head and neck, melanoma, ovarian cancer, and refractory chronic myelogenous leukemia. It is also prescribed for sickle cell disease to reduce painful crises and the need for blood transfusions, as well as for polycythemia vera and essential thrombocythemia.

Hydroxyurea inhibits the enzyme ribonucleotide reductase, which is responsible for converting ribonucleotides to deoxyribonucleotides—the building blocks of DNA. By blocking this conversion, it prevents DNA synthesis and replication in rapidly dividing cells, ultimately suppressing their growth and proliferation.

Hydroxyurea can cause significant bone marrow suppression, requiring regular blood count monitoring. It is teratogenic and contraindicated during pregnancy. Patients should avoid live vaccines while taking this medication. Common side effects include myelosuppression, nausea, and skin changes. Long-term use may increase the risk of secondary malignancies.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed August 24, 2026. · Read our editorial policy