Substance / Medication

Hydroxyurea

Overview

Active Ingredient
hydroxyurea
RxNorm CUI
5552

Indications

XROMI is indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age and older with sickle cell anemia with recurrent moderate to severe painful crises.

Labeler: Nova Laboratories, Ltd.Updated: 2026-02-02T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

Myelosuppression: Warnings and Precautions(5.1) [see] XROMI 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: Warnings and Precaution

Contraindications

When this intervention should not be used

XROMI is contraindicated in patients: Adverse Reactions (6) [see] who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation..

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Clinical Trials

202 trials linked to this intervention

202
Total Trials
51
Recruiting
68
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Impact of telehealth on hydroxyurea adherence and clinical outcomes in sickle cell disease management: A systematic review and meta-analysis.
Akosah Akwasi, Gokhale Pooja, Villa Zapata Lorenzo · J Manag Care Spec Pharm · 2026
PMID: 41439376Meta-AnalysisFull text (PMC)
The Indian experience with hydroxyurea in sickle cell disease: A 25-year systematic review.
Jain Dipty, Sarvaiya Devang, Mehta Sucheta et al. · Indian J Med Res · 2025
PMID: 40991222Meta-AnalysisFull text (PMC)
Safety of Hydroxyurea in Pregnancy: A Systematic Review of the Literature.
Al Sulaimani Ruqaiya, Zitoun Natalie, Alothman Hessah et al. · J Obstet Gynaecol Can · 2025
PMID: 40381805Meta-Analysis
Therapeutic Role of Hydroxyurea in Paediatric Hydroxyurea Pertussis:.
Alhamoud Abdullah H, Suhaqi Mohammed Y, Arishi Qasem A et al. · Sultan Qaboos Univ Med J · 2025
PMID: 41536513Meta-AnalysisFull text (PMC)
Role of hydroxyurea therapy in the prevention of organ damage in sickle cell disease: a systematic review and meta-analysis.
Khargekar Naveen, Banerjee Anindita, Athalye Shreyasi et al. · Syst Rev · 2024
PMID: 38331925Meta-AnalysisFull text (PMC)
Hydroxyurea at escalated dose versus fixed low-dose hydroxyurea in adults with sickle cell disease.
Ogu Ugochi O, Mukhopadhyay Ayesha, Patel Kruti et al. · Eur J Haematol · 2024
PMID: 38019026Meta-AnalysisFull text (PMC)
Efficacy and safety of hydroxyurea therapy on patients with-thalassemia: a systematic review and meta-analysis.
Huang Tianmin, Jiang Huixian, Tang Ganling et al. · Front Med (Lausanne) · 2024
PMID: 39882530Meta-AnalysisFull text (PMC)
Effects of hydroxyurea on fertility in male and female sickle cell disease patients. A systemic review and meta-analysis.
Sewaralthahab Sarah, Alsubki Lujain A, Alhrabi Maram S et al. · PLoS One · 2024
PMID: 38848387Meta-AnalysisFull text (PMC)
A systematic review on hydroxyurea therapy for sickle cell disease in India.
Pandey Apoorva, Kaur Harpreet, Borah Sapan et al. · Indian J Med Res · 2022
PMID: 36629190Meta-AnalysisFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Hydroxycarbamide (substance)
SNOMED CT
387314007
UMLS CUI
C0020402
RxNorm CUI
5552
Labeler
Nova Laboratories, Ltd.

Clinical Data

This intervention maps to 13 entities in the Healos knowledge graph.

13
Conditions
0
Biomarkers
0
Specialists
0
Symptoms
202
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.