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Prescription medicine

Rifaximin

Brand names: Xifaxan

Drug class: Rifamycin Antibacterial

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
3Companies
2004First FDA approval on file

Quick answers

What is Rifaximin used for?
The FDA-approved label (Xifaxan, Cardinal Health 107, LLC, August 27, 2025) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Rifaximin have a boxed warning?
No. None of the 3 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Rifaximin?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Rifaximin been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Rifaximin?
3 companies list prescription products of Rifaximin in the FDA NDC Directory, including Salix Pharmaceuticals, Inc., A-S Medication Solutions and Cardinal Health 107, LLC.

What Rifaximin is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

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. …

— FDA label: Xifaxan, Cardinal Health 107, LLC, effective August 27, 2025. Read the full label on DailyMed →

The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Irritable bowel syndrome (IBS)

Related medical specialties

Gastroenterology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 3 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet
RouteOral
Prescription products4 in the FDA NDC Directory
Brand namesXifaxan

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA021361
XIFAXAN		 Salix PharmsMay 25, 2004 13, latest October 19, 2023
2023: Labeling · 2022: Labeling · 2020: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)429662, 539789, 856664, 856666
SPL set ID of the quoted label7afafa63-3236-4212-9589-045db6b01c0b
FDA labels (SPL)3
FDA applicationsNDA021361
Active ingredients (FDA)RIFAXIMIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Xifaxan, Cardinal Health 107, LLC, effective August 27, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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