Prescription medicine
Nitazoxanide First approved as Alinia
Nitazoxanide (Alinia) is a prescription medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $82.20 per nitazoxanide 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the nitazoxanide FDA label on DailyMed (effective October 9, 2025, Rising Pharma Holdings, Inc.); the NDA 21498 record on Drugs@FDA; every nitazoxanide label on DailyMed.
Highlights of the record
FDA label of October 9, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDiarrhea 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.
Forms and strengths
- 500 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- November 22, 2002 Alinia, Romark; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first November 27, 2020; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 4 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $82.20 per tablet Nitazoxanide 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 343 through July 30, 2026
What is nitazoxanide used for?
From the label: indications and usageDiarrhea 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) ]. Nitazoxanide tablets are antiprotozoal indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum (1). […]
Conditions named in the indications of nitazoxanide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Antiprotozoal.
Source: FDA drug label (Nitazoxanide), Rising Pharma Holdings, Inc., effective October 9, 2025 (SPL set c0dc0656-3c46-43f9-adea-5285c522cef8), via openFDA; the full label on DailyMed
Is there a generic for nitazoxanide (Alinia)?
The FDA approved the first generic nitazoxanide on November 27, 2020. 3 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists nitazoxanide from 4 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2002 earliest approval on file
- 2020 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for nitazoxanide (Alinia)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $82.20 per Nitazoxanide 500 mg tablet, down 15% from $96.73 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Nitazoxanide 500 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nitazoxanide 500 mg tablet | Generic | $82.20 per tablet | $2,465.91 | -15% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the nitazoxanide label say about other medicines?
The nitazoxanide label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Warfarin | drug interactions | Therefore, monitor for adverse reactions when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g., warfarin). |
Source: FDA drug label (Nitazoxanide), Rising Pharma Holdings, Inc., effective October 9, 2025 (SPL set c0dc0656-3c46-43f9-adea-5285c522cef8), via openFDA; the full label on DailyMed
What do FAERS reports show for nitazoxanide?
The FDA Adverse Event Reporting System holds 343 reports that list nitazoxanide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 71 are coded as a death and 139 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as nitazoxanide?
10 other medicines are given the same way (oral) and in the same FDA class as nitazoxanide or labeled mainly for the same use (diarrhea), the same class first. Diarrhea lists all 16 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Bismuth subsalicylate | Diarrhea | none listed | $0.0817 per tablet 262 mg tablet chewable | No current entry |
| Loperamide | Diarrhea | 98 labelers | $0.0549 per capsule 2 mg capsule | No current entry |
| Ciprofloxacin | Diarrhea | 46 labelers | $0.123 per tablet 500 mg tablet | No current entry |
| Dimethicone and loperamide | Diarrhea | 33 labelers | $0.286 per unit Gs anti-diarrheal-antigas cplt | No current entry |
| Atropine and diphenoxylate | Diarrhea | 19 labelers | $0.139 per tablet 2.5-0.025 mg tablet | No current entry |
| Rifaximin | Diarrhea | none listed | n/a | No current entry |
| Atropine and difenoxin | Diarrhea | none listed | $6.91 per tablet 1-0.025 mg tablet | No current entry |
| Octreotide | Diarrhea | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as nitazoxanide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to nitazoxanide
- 10 medicines for the same use
- Other antiprotozoals
- the pharmacologic class, with prices and generics
- Nitazoxanide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other