FDA label
What is Xifaxan used for?
Xifaxan contains rifaximin. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Xifaxan lists 3 uses: Travelers’ Diarrhea; Hepatic Encephalopathy; Irritable Bowel Syndrome with Diarrhea.
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Xifaxan, tablet
Indications and Usage, quoted from the label by Salix Pharmaceuticals, Inc. (NDA021361). Cross-references to other label sections are left out.
To 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.
Travelers’ Diarrhea
XIFAXAN is indicated for the treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adults and pediatric patients 12 years of age and older.
Limitations of Use
XIFAXAN should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli.
Hepatic Encephalopathy
XIFAXAN is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.
In the placebo-controlled trial of XIFAXAN for HE, 91% of the patients were using lactulose concomitantly. Differences in the treatment effect of those patients not using lactulose concomitantly could not be assessed.
XIFAXAN has not been studied in patients with MELD (Model for End-Stage Liver Disease) scores >25, and only 8.6% of patients in the placebo-controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction.
Irritable Bowel Syndrome with Diarrhea
XIFAXAN is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Source: DailyMed label, set id c5e8e2fd-7087-4b78-9181-cc259c0be2f1, version 50, effective June 25, 2025. NDC 65649-301, one of 4 listings for this product.
Questions
What is Xifaxan used for?
The FDA label for Xifaxan lists 3 uses: Travelers’ Diarrhea; Hepatic Encephalopathy; Irritable Bowel Syndrome with Diarrhea.
What drug class is Xifaxan?
FDA lists rifaximin in the Rifamycin Antibacterial established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.