Prescription medicine
Rifaximin Brand names: Xifaxan
Rifaximin (Xifaxan) is a prescription medicine with an FDA approval on record since 2004. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the rifaximin FDA label on DailyMed (effective June 25, 2025, Salix Pharmaceuticals, Inc.); the NDA 21361 record on Drugs@FDA; every rifaximin label on DailyMed.
Highlights of the record
FDA label of June 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Forms and strengths
- 200 mg
- 550 mg
Tablet.
On the market
- Earliest approval on file
- May 25, 2004 Xifaxan, Salix Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first March 19, 2026; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- October 2, 2029 Xifaxan tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 20,826 through July 30, 2026
What is rifaximin used for?
From the label: indications and usageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. […]
Conditions named in the indications of rifaximin's FDA labels, with every medicine labeled for each:
From other rifaximin labelsDiarrhea: Treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adult and pediatric patients 12 years of age and older.
Irritable bowel syndrome: Syndrome with Diarrhea XIFAXAN is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
FDA pharmacologic class: Rifamycin Antibacterial.
Source: FDA drug label (XIFAXAN), Salix Pharmaceuticals, Inc., effective June 25, 2025 (SPL set c5e8e2fd-7087-4b78-9181-cc259c0be2f1), via openFDA; the full label on DailyMed
Is there a generic for rifaximin (Xifaxan)?
The FDA approved the first generic rifaximin on March 19, 2026. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 7 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 20 patents for Xifaxan tablets: the compound patent runs to September 2, 2027, and the last listed entry to October 2, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2004 earliest approval on file
- 2026 first generic approved
- 2029 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has rifaximin been recalled?
The FDA's Enforcement Report lists 1 recall naming rifaximin since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of rifaximin and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; rifAXIMin Tablet, 200 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 25 mg, NDC 00143117201, Pedigree: AD52778_19, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the rifaximin label say about other medicines?
The rifaximin label names 2 other medicines 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 |
|---|---|---|
| Cyclosporine | drug interactions | Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs significantly increased the systemic exposure of rifaximin. |
| Warfarin | drug interactions | DRUG INTERACTIONS Warfarin: Monitor INR and prothrombin time; dose adjustment of warfarin may be needed to maintain target INR range. |
Source: FDA drug label (XIFAXAN), Salix Pharmaceuticals, Inc., effective June 25, 2025 (SPL set c5e8e2fd-7087-4b78-9181-cc259c0be2f1), via openFDA; the full label on DailyMed
What do FAERS reports show for rifaximin?
The FDA Adverse Event Reporting System holds 20,826 reports that list rifaximin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,105 are coded as a death and 8,176 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.
Reports received each year
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 rifaximin?
11 other medicines are given the same way (oral) and in the same FDA class as rifaximin 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 |
| Nitazoxanide | Diarrhea | 4 labelers | $82.20 per tablet 500 mg tablet | No current entry |
| Eluxadoline | Irritable bowel syndrome, Diarrhea | none listed | $28.09 per tablet 100 mg tablet | No current entry |
| Atropine and difenoxin | Diarrhea | none listed | $6.91 per tablet 1-0.025 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to rifaximin
- 11 medicines for the same use
- Other rifamycin antibacterials
- the pharmacologic class, with prices and generics
- Rifaximin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other