Hydroxyurea

DRUG INFORMATION

  ADULT
    - 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 capsules by 50% in patients with
      creatinine clearance less than 60 mL/min. (2.3, 8.6, 12.3) 2.1 Dosing Information
      Hydroxyurea capsules are used alone or in conjunction with other antitumor agents
      or radiation therapy to treat neoplastic diseases.
      Source: US FDA label for hydroxyurea (Hydroxyurea), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients have not been established.
      Source: US FDA label for hydroxyurea (Hydroxyurea), section 'pediatric use',
      retrieved 2026-08-29
    - 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 capsules by 50% in patients with
      creatinine clearance less than 60 mL/min. (2.3, 8.6, 12.3) 2.1 Dosing Information
      Hydroxyurea capsules are used alone or in conjunction with other antitumor agents
      or radiation therapy to treat neoplastic diseases.
      Source: US FDA label for hydroxyurea (Hydroxyurea), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - (2.1) Renal impairment: Reduce the dose of hydroxyurea capsules by 50% in patients
      with creatinine clearance less than 60 mL/min.
      Source: US FDA label for hydroxyurea (Hydroxyurea), section 'dosage and
      administration', retrieved 2026-08-29
    - Severe anemia must be corrected before initiating therapy with hydroxyurea
      capsules. 2.2 Dose Modifications for Toxicity Monitor for the following and reduce
      the dose or discontinue hydroxyurea capsules accordingly: • Myelosuppression [ see
      Warnings and Precautions (5.1) ]. • Cutaneous vasculitis [ see Warnings and
      Precautions (5.5) ] Consider dose modifications for other toxicities.
      Source: US FDA label for hydroxyurea (Hydroxyurea), section 'dosage and
      administration', retrieved 2026-08-29
    - Creatinine Clearance (mL/min) Recommended Hydroxyurea Capsules Initial Dose (mg/kg
      once daily) ≥60 15 <60 or ESRD* 7.5 *On dialysis days, administer hydroxyurea
      capsules to patients following hemodialysis.
      Source: US FDA label for hydroxyurea (Hydroxyurea), section 'dosage and
      administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Reduce dosage and closely monitor the hematologic parameters when hydroxyurea
      capsules is to be administered to these patients [ see Dosage and Administration
      (2.3) and Clinical Pharmacology (12.3) ]. 8.7 Hepatic Impairment There are no data
      that support specific guidance for dosage adjustment in patients with hepatic
      impairment.
      Source: US FDA label for hydroxyurea (Hydroxyurea), section 'use in specific
      populations', retrieved 2026-08-29

  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) ].
      Source: US FDA label for hydroxyurea (Hydroxyurea), section 'pregnancy', retrieved
      2026-08-29
    - There are no data with hydroxyurea capsules use in pregnant women to inform a
      drug-associated risk.
      Source: US FDA label for hydroxyurea (Hydroxyurea), section 'pregnancy', retrieved
      2026-08-29
    - 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 ).
      Source: US FDA label for hydroxyurea (Hydroxyurea), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Pregnancy Testing Verify the pregnancy status of females of reproductive potential
      prior to initiating hydroxyurea capsules therapy.
      Source: US FDA label for hydroxyurea (Hydroxyurea), section 'nursing mothers',
      retrieved 2026-08-29
    - Contraception Females Hydroxyurea capsules can cause fetal harm when administered
      to a pregnant woman [ see Use in Specific Populations (8.1) ].
      Source: US FDA label for hydroxyurea (Hydroxyurea), section 'nursing mothers',
      retrieved 2026-08-29
    - Advise females of reproductive potential to use effective contraception during and
      after treatment with hydroxyurea capsules for at least 6 months after therapy.
      Source: US FDA label for hydroxyurea (Hydroxyurea), section 'nursing mothers',
      retrieved 2026-08-29