pharmacopeia
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/api/v1/drug/hydroxyurea

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Ribonucleotide Reductase Inhibitors.

Ribonucleotide Reductase

Indications

Sourced from openFDA
  • Hydroxyurea capsules, USP is 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.ICD-10: C95.90

Contraindications

Sourced from openFDA
  • Hydroxyurea capsules is 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.contraindicated

Dosage & administration

Sourced from openFDA

Individualize treatment based on tumor type, disease state, response to treatment, patient risk factors, and current clinical practice standards. (2.1) Renal impairment: Reduce the dose of hydroxyurea by 50% in patients with creatinine clearance less than 60 mL/min. ( 2.3 , 8.6, 12.3 ) 2.1 Dosing Information Hydroxyurea is used alone or in conjunction with other antitumor agents or radiation therapy to treat neoplastic diseases. Individualize treatment based on tumor type, disease state, response to treatment, patient risk factors, and current clinical practice standards. Base all dosage on the patient’s actual or ideal weight, whichever is less. Hydroxyurea is a cytotoxic drug. Follow applicable special handling and disposal procedures [ see References (15) ]. Swallow hydroxyurea capsule whole. Do NOT open, break, or chew capsules because hydroxyurea is a cytotoxic drug. Prophylactic administration of folic acid is recommended [ see Warnings and Precautions (5.8) ]. Monitor blood counts at least once a week during hydroxyurea therapy. Severe anemia must be corrected before initiating therapy with hydroxyurea.

Warnings & precautions

Sourced from openFDA

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. (5.1) Hemolytic anemia: Monitor blood counts throughout treatment. If hemolysis persists, discontinue Hydroxyurea. (5.2) Malignancies: Advise protection from sun exposure and monitor for secondary malignancies. ( 5.3) Embryo-Fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. ( 5.4 , 8.1 , 8.3 ) Vasculitic toxicities: Discontinue hydroxyurea and initiate treatment if this occurs. (5.5) Live Vaccinations: Avoid live vaccine use in a patient taking hydroxyurea capsules. (5.6) Risks with concomitant use of antiretroviral drugs: Pancreatitis, hepatotoxicity, and neuropathy have occurred. Monitor for signs and symptoms in patients with HIV infection using antiretroviral drugs; discontinue hydroxyurea capsules and implement treatment. (5.7) Radiation recall: Monitor for skin erythema in patients who previously received radiation and manage symptomatically. (5.8) 5.1 Myelosuppression s ion Hydroxyurea causes severe myelosuppression. Treatment with hydroxyurea should not be initiated if bone marrow function is markedly depressed. Bone marrow suppression may occur, and leukopenia is generally its first and most common manifestation. Thrombocytopenia and anemia occur less often and are seldom seen without a preceding leukopenia.

Adverse reactions

Sourced from openFDA

• 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) ] • Radiation recall [see Warnings and Precautions (5.8) ] • Macrocytosis [see Warnings and Precautions (5.9) ] • Pulmonary Toxicity [see Warnings and Precautions (5.10) ] Most common adverse reactions (≥30%) are hematological, gastrointestinal symptoms, and anorexia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Leading Pharma, LLC at 1-844-740-7500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Postmarketing Experience The following adverse reactions have been identified during post-approval use of hydroxyurea capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Use in specific populations

Sourced from openFDA

Lactation: Advise women not to breastfeed. (8.2) Geriatric Use: Care should be taken in dose selection and may require a lower dose regimen and monitoring of renal function. (8.5) 8.1 Pregnancy Risk Summary Hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology (12.1) ]. There are no data with hydroxyurea capsules use in pregnant women to inform a drug-associated risk. In animal reproduction studies, administration of hydroxyurea to pregnant rats and rabbits during organogenesis produced embryotoxic and teratogenic effects at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m 2 basis (see Data). Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with hydroxyurea capsules. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. Data Animal Data Hydroxyurea has been demonstrated to be a potent teratogen in a wide variety of animal models, including mice, hamsters, cats, miniature swine, dogs, and monkeys at doses within 1-fold of the human dose given on a mg/m 2 basis.

Overdosage

Sourced from openFDA

Acute mucocutaneous toxicity has been reported in patients receiving hydroxyurea at dosages several times the therapeutic dose. Soreness, violet erythema, edema on palms and soles followed by scaling of hands and feet, severe generalized hyperpigmentation of the skin, and stomatitis have also been observed.

Approval history

Sourced from openFDA
  • Dec 7, 1967NDANDA016295Waylis Therap
  • Oct 16, 1998ANDAANDA075143Barr
  • Feb 24, 1999ANDAANDA075340Ph Health
  • Dec 21, 2017NDANDA208843Theravia
  • Apr 8, 2020ANDAANDA213438Leading
  • Mar 6, 2024ANDAANDA218021Qilu
  • Apr 4, 2024NDANDA216593Nova Labs Ltd

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
20,707 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use2,11910%
  2. 2Fatigue1,5207.3%
  3. 3Sickle Cell Anaemia With Crisis1,4807.1%
  4. 4Diarrhoea1,3906.7%
  5. 5Nausea1,2916.2%
  6. 6Headache1,0545.1%
  7. 7Anaemia1,0325.0%
  8. 8Death1,0244.9%
  9. 9Haemoglobin Decreased9374.5%
  10. 10Pyrexia9184.4%
  11. 11Drug Ineffective8924.3%
  12. 12Pain8574.1%
  13. 13Product Dose Omission Issue8173.9%
  14. 14Dyspnoea8143.9%
  15. 15Pneumonia7603.7%

Literature

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Recent PubMed references pinned to Hydroxyurea as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 349 ClinicalTrials.gov registrations naming Hydroxyurea as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Hydroxyurea work?
Mechanism-of-action class: Ribonucleotide Reductase Inhibitors.
What is Hydroxyurea used for?
According to FDA labeling, Hydroxyurea carries indications including: Hydroxyurea capsules, USP is 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Hydroxyurea?
Hydroxyurea is classified as Other antineoplastic agents, Antimetabolite, Ribonucleotide Reductase Inhibitors, Decreased DNA Integrity.
What are the brand names for Hydroxyurea?
Hydroxyurea is marketed under brand names including Droxia, Hydrea, Siklos, Xromi.
What are the contraindications for Hydroxyurea?
Hydroxyurea labeling lists contraindications including: Hydroxyurea capsules is 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.. Always consult the full prescribing information and a clinician.
Note. Data for hydroxyurea is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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