Hydroxyurea
Brand Names: Droxia, Hydrea, Siklos, Xromi
Methodology & AI Transparency ⓘ
Hydroxyurea Key Takeaways
Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level
- 1 What it does: Hydroxyurea capsules are indicated for the treatment of: Resistant chronic myeloid leukemia.
- 2 Real-world patient consensus: Zero-PHI community consensus: 87% favorable across 6 logged regimens (Droxia, Hydrea).
- 3 Typical cash cost range: Public pharmacy ledger: $8.23 low cash benchmark vs. $34.50 chain retail average ($0.1836/unit CMS NADAC).
- 4 Top reported side effects / signs: Primary clinical safety signals tracked in FAERS for Hydroxyurea include decreased appetite (5.6%), nausea (7.7%), headache (7.8%).
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Hydroxyurea Mechanism, CYP450 Pathways & DailyMed Monograph
Hydroxyurea capsules are 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. Hydroxyurea capsules are 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. ( 1 )
12.1 Mechanism of Action The precise mechanism by which hydroxyurea produces its antineoplastic effects cannot, at present, be described. However, the reports of various studies in tissue culture in rats and humans lend support to 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. This hypothesis explains why, under certain conditions, hydroxyurea may induce teratogenic effects.
Following administration (500 mg/1 Capsule), Hydroxyurea achieves Oral fraction absorbed ranges from 51% to 63% (Hydroxyurea 500) bioavailability and peak plasma tmax within 1 to 4 hours (hydroxyurea) onset, governed by a Mean elimination half-life of 4 to 16 hours across adult Hydroxyurea dosing terminal half-life through dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of hydroxyurea.
Before initiating Hydroxyurea at 500 mg/1 Capsule, clinical safety checklists rule out hydroxyurea capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.; in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation.. Logged tolerability patterns center on headache (7.8% of reports), nausea (7.7% of reports), dizziness (6.5% of reports).
Reconcile eGFR-adjusted medications before escalating Hydroxyurea in polypharmacy regimens.
Botanical enzyme modulators may alter oral first-pass exposure of Hydroxyurea; disclose all supplements.
Standard Adult Titration & Dosages
Absolute & Relative Contraindications
- Hydroxyurea capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.
- In patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation.
Logged Side-Effect Incidence (6 Reports)
Hydroxyurea Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs
Peer-Reviewed Human Clinical Trials & Meta-Analyses (Hydroxyurea)
| Study & Plain-English Finding | Sample (N) | Rigor | Primary Source |
|---|---|---|---|
| Can This Approach Help? Inside the Latest Research on Hydroxyurea for secondary stroke prevention in children with sickle cell anemia No participant had hydroxyurea therapy stopped for myelosuppression. Blood • 2023-02-23 • Phase III Randomized Trial | N = 101 | 88/100 | PMID 36322937 ↗ |
| Can This Approach Help? Inside the Latest Research on Heart and blood vessel Safety of Anagrelide Hydrochloride versus Hydroxyurea in These results suggest that long-term treatment with anagrelide is not associated with adverse effects on cardiac function. Cardiovascular toxicology • 2021-03-15 • Phase III Randomized Trial | N = 75 | 82/100 | PMID 33123978 ↗ |
Hydroxyurea Public Price Transparency Ledger
| Dispensing Channel / Benchmark | Verification Source | Reference Cost | Details |
|---|---|---|---|
| Pharmacy Acquisition Cost (CMS NADAC) | CMS Medicaid NADAC Weekly National Survey | $0.1836/unit (~$5.51/30u) | Wholesale baseline |
| Mark Cuban Cost Plus Drugs (Mail-Order Generic) | Public Wholesale Price List (NADAC + 15% + pharmacy fee) | $8.23 / mo | Formulary listing ↗ |
| Average U.S. Walk-In Retail Cash Price | Chain Pharmacy Uninsured Cash Index | $34.50 / mo | Before coupon/insurance |
| Patient-Logged Out-of-Pocket Average | 6 Anonymous DotMD Community Micro-Logs | $9.46 / mo | View logs ↓ |
Hydroxyurea Federal Verification & Benchmark Summary
| Metric | Verified Benchmark | Source |
|---|---|---|
| Hydroxyurea RxNorm Concept ID | 197797 | U.S. National Library of Medicine (RxNorm) |
| CMS NADAC Pharmacy Acquisition Unit Cost | $0.1836 / unit | CMS Medicaid NADAC Weekly Feed |
| Walk-In Chain Pharmacy Cash Average | $34.50 / mo | U.S. Uninsured Retail Cash Index |
| Public Mail-Order Wholesale Benchmark | $8.23 / mo (Cost Plus Drugs) | Mark Cuban Cost Plus Public API |
| Real-World Patient Consensus | 87.00% Worth It (6 anonymous logs) | DotMD Zero-PHI Patient Ledger |
Hydroxyurea Patient Community, Cohort Filters & Dosage Logs
Evidence synthesis for Hydroxyurea: FDA labeling (2026-05-07, NDC 49884-724), CYP/interaction screening, and public pharmacy acquisition costs.
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