Nitazoxanide

DRUG INFORMATION

  ADULT
    - Recommended Dosage Age Dosage Duration 12 years and older One Nitazoxanide tablet
      (500 mg nitazoxanide) taken orally every 12 hours with food 3 days
      Source: US FDA label for nitazoxanide (Nitazoxanide), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and efficacy of ALINIA for Oral Suspension for the treatment of
      diarrhea caused by G. lamblia or C. parvum in pediatric patients 1 to 11 years of
      age has been established based on three (3) randomized, controlled studies with
      104 pediatric subjects treated with ALINIA for Oral Suspension 100 mg/5 mL.
      Furthermore, the safety and efficacy of ALINIA for Oral Suspension for the
      treatment of diarrhea caused by G. lamblia or C.
      Source: US FDA label for nitazoxanide (Nitazoxanide), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for nitazoxanide (Nitazoxanide),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - In general, the greater frequency of decreased hepatic, renal, or cardiac
      function, and of concomitant disease or other drug therapy in elderly patients
      should be considered when prescribing nitazoxanide tablets and Alinia for oral
      suspension. 8.6 Renal and Hepatic Impairment The pharmacokinetics of nitazoxanide
      in patients with compromised renal or hepatic function has not been studied.
      Source: US FDA label for nitazoxanide (Nitazoxanide), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary There are no data with nitazoxanide in pregnant women to inform a
      drug-associated risk.
      Source: US FDA label for nitazoxanide (Nitazoxanide), section 'pregnancy',
      retrieved 2026-08-29
    - No teratogenicity or fetotoxicity was observed in animal reproduction studies with
      administration of nitazoxanide to pregnant rats and rabbits during organogenesis
      at exposures 30 and 2 times, respectively, the exposure at the maximum recommended
      human dose of 500 mg twice daily based on body surface area (BSA).
      Source: US FDA label for nitazoxanide (Nitazoxanide), section 'pregnancy',
      retrieved 2026-08-29
    - In the U.S. general population, the estimated background risk of major birth
      defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15%
      to 20%, respectively.
      Source: US FDA label for nitazoxanide (Nitazoxanide), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Oral treatment of pregnant rabbits with nitazoxanide during organogenesis resulted
      in minimal maternal toxicity and no external fetal anomalies. 8.2 Lactation Risk
      Summary No information regarding the presence of nitazoxanide in human milk, the
      effects on the breastfed infant, or the effects on milk production is available.
      Source: US FDA label for nitazoxanide (Nitazoxanide), section 'use in specific
      populations', retrieved 2026-08-29
    - The development and health benefits of breastfeeding should be considered along
      with the mother’s clinical need for nitazoxanide and any potential adverse effects
      on the breastfed infant from nitazoxanide or from the underlying maternal
      condition. 8.4 Pediatric Use The safety and efficacy of ALINIA for Oral Suspension
      for the treatment of diarrhea caused by G. lamblia or C.
      Source: US FDA label for nitazoxanide (Nitazoxanide), section 'use in specific
      populations', retrieved 2026-08-29