Hydroxychloroquine

DRUG INFORMATION

  ADULT
    - Malaria in Adult and Pediatric Patients ( 2.2 ): Prophylaxis: Begin weekly doses 2
      weeks prior to travel to the endemic area, continue weekly doses while in the
      endemic area, and continue the weekly doses for 4 weeks after leaving the endemic
      area: - Adults: 400 mg once a week - Pediatric patients ≥ 31 kg: 6.5 mg/kg up to
      400 mg, once a week Treatment of Uncomplicated Malaria: See Full Prescribing
      Information (FPI) for complete dosing information.
      Source: US FDA label for hydroxychloroquine (Hydroxychloroquine Sulfate), section
      'dosage and administration', retrieved 2026-08-29
    - Do not crush or divide the tablets. 2.2 Dosage for Malaria in Adult and Pediatric
      Patients Hydroxychloroquine sulfate tablets are not recommended in pediatric
      patients less than 31 kg because the lowest available strength (200 mg) exceeds
      the recommended dose for these patients and it cannot be divided.
      Source: US FDA label for hydroxychloroquine (Hydroxychloroquine Sulfate), section
      'dosage and administration', retrieved 2026-08-29
    - The recommended prophylaxis dosage is: Adult patients: 400 mg once a week
      Pediatric patients ≥ 31 kg: 6.5 mg/kg actual body weight (up to 400 mg) once a
      week Treatment of Uncomplicated Malaria The dosages for the treatment of
      uncomplicated malaria are: Adult patients: Administer 800 mg initially;
      subsequently administer 400 mg at 6 hours, 24 hours, and 48 hours after the
      initial dose (total dosage = 2,000 mg).
      Source: US FDA label for hydroxychloroquine (Hydroxychloroquine Sulfate), section
      'dosage and administration', retrieved 2026-08-29

  CHILD
    - Clinical trials of hydroxychloroquine sulfate did not include sufficient numbers
      of patients 65 years of age and older to determine whether they respond
      differently from younger adult patients. Nevertheless, this drug is known to be
      substantially excreted by the kidney, and the risk of toxic reactions to this drug
      may be greater in patients with impaired renal function.
      Source: US FDA label for hydroxychloroquine (Hydroxychloroquine Sulfate), section
      'pediatric use', retrieved 2026-08-29
    - Malaria in Adult and Pediatric Patients ( 2.2 ): Prophylaxis: Begin weekly doses 2
      weeks prior to travel to the endemic area, continue weekly doses while in the
      endemic area, and continue the weekly doses for 4 weeks after leaving the endemic
      area: - Adults: 400 mg once a week - Pediatric patients ≥ 31 kg: 6.5 mg/kg up to
      400 mg, once a week Treatment of Uncomplicated Malaria: See Full Prescribing
      Information (FPI) for complete dosing information.
      Source: US FDA label for hydroxychloroquine (Hydroxychloroquine Sulfate), section
      'dosage and administration', retrieved 2026-08-29
    - Do not crush or divide the tablets. 2.2 Dosage for Malaria in Adult and Pediatric
      Patients Hydroxychloroquine sulfate tablets are not recommended in pediatric
      patients less than 31 kg because the lowest available strength (200 mg) exceeds
      the recommended dose for these patients and it cannot be divided.
      Source: US FDA label for hydroxychloroquine (Hydroxychloroquine Sulfate), section
      'dosage and administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Risk factors for retinal damage include daily hydroxychloroquine sulfate dosages ≥
      5 mg/kg of actual body weight, durations of use greater than five years, renal
      impairment, use of concomitant drug products such as tamoxifen citrate, and
      concurrent macular disease.
      Source: US FDA label for hydroxychloroquine (Hydroxychloroquine Sulfate), section
      'warnings and cautions', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for hydroxychloroquine
      (Hydroxychloroquine Sulfate), retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors
      pregnancy outcomes in women exposed to hydroxychloroquine sulfate during
      pregnancy.
      Source: US FDA label for hydroxychloroquine (Hydroxychloroquine Sulfate), section
      'pregnancy', retrieved 2026-08-29
    - Encourage patients to register by contacting 1-877-311-8972.
      Source: US FDA label for hydroxychloroquine (Hydroxychloroquine Sulfate), section
      'pregnancy', retrieved 2026-08-29
    - Risk Summary Prolonged clinical experience over decades of use and available data
      from published epidemiologic and clinical studies with hydroxychloroquine sulfate
      use in pregnant women have not identified a drug-associated risk of major birth
      defects, miscarriage, or adverse maternal, or fetal outcomes (see Data) .
      Source: US FDA label for hydroxychloroquine (Hydroxychloroquine Sulfate), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - The safety and effectiveness of hydroxychloroquine sulfate have been established
      in pediatric patients for the treatment of uncomplicated malaria due to P.
      falciparum, P. malariae, P. vivax , and P. ovale, as well as for the prophylaxis
      of malaria in geographic areas where chloroquine resistance is not reported.
      Source: US FDA label for hydroxychloroquine (Hydroxychloroquine Sulfate), section
      'nursing mothers', retrieved 2026-08-29
    - However, this product cannot be directly administered to pediatric patients
      weighing less than 31 kg because the film-coated tablets cannot be crushed or
      divided [see Dosage and Administration (2.1 , 2.2) ] .
      Source: US FDA label for hydroxychloroquine (Hydroxychloroquine Sulfate), section
      'nursing mothers', retrieved 2026-08-29
    - The safety and effectiveness of hydroxychloroquine sulfate have not been
      established in pediatric patients for the treatment of rheumatoid arthritis,
      chronic discoid lupus erythematosus, or systemic lupus erythematosus.
      Source: US FDA label for hydroxychloroquine (Hydroxychloroquine Sulfate), section
      'nursing mothers', retrieved 2026-08-29