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MedsAcross

Molecule

Nitazoxanide

Antiprotozoal
Available on requestOrphan
Presentations
1
Brands
0
Manufacturers
0
Available from stock
0

Nitazoxanide is an antiprotozoal indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. It is available as tablets for oral use. MedsAcross supplies Nitazoxanide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Antiprotozoal
ATC classification
P01AX11 Nitazoxanide · Antiprotozoals, including antimalarials, subgroup P01A, subgroup P01AX
US FDA first approval
22 November 2002
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII SOA12P041NRxCUI 31819CAS 55981-09-4DrugBank DB00507Q2943789

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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. Nitazoxanide tablets are antiprotozoal 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 C. parvum in HIV-infected or immunodeficient patients.

Source: US FDA prescribing information

Dosing overview

• Nitazoxanide tablets should not be administered to pediatric patient 11 years of age or younger. • Dosage for treatment of diarrhea caused by G.lamblia or C. parvum: Age Dosage Duration 12 years and older One 500 mg nitazoxanide tablet every 12 hours with food 3 days

Source: US FDA prescribing information

Contraindications

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

Source: US FDA prescribing information

Side effects

The most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia, and nausea.

Source: US FDA prescribing information

Interactions

Competition for binding sites may occur when administered concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices. Monitor for adverse reactions.

Source: US FDA prescribing information

Storage

Store the tablets at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Nitazoxanide, sorted by availability.

MedicineManufacturerRegisterAvailability
Nitazoxanide 500 mg tabletOralGeneric name—US FDAAvailable on request

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 22 November 2002Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Nitazoxanide in public data. This is not a list of approved uses, see the clinical information.

Cryptosporidiosis Fasciolosis Giardiasis

Questions and answers

Is Nitazoxanide available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Nitazoxanide and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Nitazoxanide approved by the US FDA?

Yes. The US FDA first approved Nitazoxanide on 22 November 2002, according to Drugs@FDA.

Does Nitazoxanide need cold chain shipping?

No listed presentation of Nitazoxanide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Nitazoxanide in?

Nitazoxanide is classified under ATC code P01AX11 (Nitazoxanide).

References

  1. Nitazoxanide prescribing information (Camber Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 30 December 2025

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