Nitazoxanide

Nitazoxanide is an antiprotozoal [see Microbiology ( 12.4 )].

• Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum . Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2) ] .ICD-10: B20

• Hypersensitivity ( 4.1 ) 4.1 Hypersensitivity Nitazoxanide tablets are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.contraindicated

• Nitazoxanide tablets should not be administered to pediatric patient 11 years of age or younger ( 2.1 ). • Dosage for treatment of diarrhea caused by G.lamblia or C. parvum ( 2.1 ): Age Dosage Duration 12 years and older One 500 mg nitazoxanide tablet every 12 hours with food 3 days 2.1 Recommended Dosage and Important Administration Instructions Important Administration Instructions for Pediatric Patients 11 years of Age or Younger: Nitazoxanide tablets should not be administered to pediatric patients 11 years of age or younger because a single tablet contains a greater amount of nitazoxanide than the recommended dosing in this pediatric age group. Table 1. Recommended Dosage Age Dosage Duration 12 years and older One 500 mg nitazoxanide tablet taken orally every 12 hours with food 3 days

The most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia, and nausea ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of nitazoxanide was evaluated in 2177 HIV-uninfected subjects 12 months of age and older who received nitazoxanide tablets or Alina for oral suspension at the recommended dose for at least three days. In pooled controlled clinical trials involving 536 HIV-uninfected subjects treated with nitazoxanide tablets or Alina for oral suspension, the most common adverse reactions were abdominal pain, headache, chromaturia and nausea (≥2%). Safety data were analyzed separately for 280 HIV-uninfected subjects ≥12 years of age receiving nitazoxanide at the recommended dose for at least three days in 5 placebo-controlled clinical trials and for 256 HIV-uninfected subjects 1 through 11 years of age in 7 controlled clinical trials. There were no differences between the adverse reactions reported for nitazoxanide-treated subjects based upon age. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of nitazoxanide.

8.1 Pregnancy Risk Summary There are no data with nitazoxanide in pregnant women to inform a drug-associated risk. 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). 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. Data Animal Data Nitazoxanide was administered orally to pregnant rats at doses of 0, 200, 800 or 3200 mg/kg/day on gestation days 6 to 15. Nitazoxanide produced no evidence of systemic maternal toxicity when administered once daily via oral gavage to pregnant female rats at levels up to 3200 mg/kg/day during the period of organogenesis. In rabbits, nitazoxanide was administered at doses of 0, 25, 50, or 100 mg/kg/day on gestation days 7 to 20. 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.

Metabolism

Absorption Single Dosing: Following oral administration of nitazoxanide tablets, the parent drug, nitazoxanide, is not detected in plasma. The pharmacokinetic parameters of the metabolites, tizoxanide and tizoxanide glucuronide are shown in Tables 2 and 3 below.

Limited information on nitazoxanide overdosage is available. In the event of overdose, gastric lavage may be appropriate soon after oral administration. Patients should be observed and given symptomatic and supportive treatment. There is no specific antidote for overdose with nitazoxanide. Because tizoxanide is highly protein bound (>99.9%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.

• Nov 27, 2020ANDAANDA213820Rising
• Feb 3, 2025ANDAANDA214844Ani Pharms
• Apr 15, 2025ANDAANDA218701Annora Pharma

1. 1Diarrhoea6620%
2. 2Drug Ineffective5517%
3. 3Off Label Use4915%
4. 4Disease Progression4514%
5. 5Dyspnoea3912%
6. 6Therapeutic Product Effect Incomplete329.7%
7. 7Chest Pain319.4%
8. 8Coma Scale Abnormal319.4%
9. 9Microsporidia Infection319.4%
10. 10Pneumocystis Jirovecii Infection319.4%
11. 11Treatment Failure278.2%
12. 12Nausea175.2%
13. 13Weight Decreased175.2%
14. 14Cryptosporidiosis Infection164.8%
15. 15Drug Interaction164.8%

The 10 most recently updated of 113 ClinicalTrials.gov registrations naming Nitazoxanide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• AGILE (Early Phase Platform Trial for COVID-19)
  Recruiting · Phase 1 · Phase 2 · Interventional · 600 enrolled · University of Liverpool
  NCT04746183updated 2026-06-01
• Nitazoxanide for Treatment of Cryptosporidium in Children
  Not yet recruiting · Phase 3 · Interventional · 480 enrolled · Johns Hopkins Bloomberg School of Public Health
  NCT06600711updated 2026-04-17
• Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)
  Recruiting · Phase 2 · Interventional · 3,800 enrolled · University of Oxford
  NCT05041907updated 2026-02-19
• Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment
  Completed · Phase 3 · Interventional · 73 enrolled · Alzheimer's Prevention and Reversal Project, Inc.
  NCT05894954updated 2026-02-18
• Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers
  Completed · Phase 1 · Interventional · 52 enrolled · Genfit
  NCT07110441updated 2026-01-16
• Four Different Experimental Drug Regimens to Standard of Care for the Treatment of Symptomatic Outpatients With COVID-19
  Completed · Phase 2 · Interventional · 192 enrolled · Shin Poong Pharmaceutical Co. Ltd.
  NCT04532931updated 2025-07-28
• Efficacy of Nitazoxanide Based Therapy vs Standard Triple Therapy in H-pylori in Children
  Completed · Interventional · 66 enrolled · Muhammad Aamir Latif
  NCT07086937updated 2025-07-25
• Comparing the Efficacy of Nitazoxanide Versus Rifaximin in Adult Patients With Irritable Bowel Syndrome Without Constipation
  Withdrawn · Phase 1 · Phase 2 · Interventional · 0 enrolled · Sadat City University
  NCT05453916updated 2025-07-14
• Nitazoxanide in Patients With Ulcerative Colitis
  Recruiting · Phase 2 · Interventional · 70 enrolled · Alexandria University
  NCT06993974updated 2025-06-27
• NNITS-Nitazoxanide for Norovirus in Transplant Patients Study
  Completed · Phase 2 · Interventional · 31 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT03395405updated 2025-05-21

Frequently asked questions

How does Nitazoxanide work?

Nitazoxanide is an antiprotozoal [see Microbiology ( 12.4 )].

What is Nitazoxanide used for?

According to FDA labeling, Nitazoxanide carries indications including: Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum . Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Nitazoxanide?

Nitazoxanide is classified as Other agents against amoebiasis and other protozoal diseases, Antiprotozoal, Uncouplers, Decreased Metabolic Rate.

What are the brand names for Nitazoxanide?

Nitazoxanide is marketed under brand names including Alinia.

What are the contraindications for Nitazoxanide?

Nitazoxanide labeling lists contraindications including: Hypersensitivity ( 4.1 ) 4.1 Hypersensitivity Nitazoxanide tablets are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.. Always consult the full prescribing information and a clinician.