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PlainMeds

Prescription medicine

Donor human stool Brand names: Rebyota

Donor human stool (Rebyota) is a prescription medicine. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the donor human stool FDA label on DailyMed (effective December 23, 2024); every donor human stool label on DailyMed.

Highlights of the record

FDA label of December 23, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI.

Forms and strengths

  • 150ml

Suspension.

On the market

Generic approvals
No generic approved
Labelers listed (NDC)
1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
230 through July 30, 2026

What is donor human stool used for?

From the label: indications and usage

REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI. REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI. ( 1 ) Limitation of Use: REBYOTA is not indicated for treatment of CDI. Limitation of Use: REBYOTA is not indicated for treatment of CDI.

Source: FDA drug label (Rebyota), Ferring Pharmaceuticals Inc., effective December 23, 2024 (SPL set 7af8a7f6-a441-4dc6-a151-138a89166fbb), via openFDA; the full label on DailyMed

Is there a generic for donor human stool (Rebyota)?

No generic donor human stool is approved (Drugs@FDA, October 8, 2026).

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for donor human stool?

The FDA Adverse Event Reporting System holds 230 reports that list donor human stool among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 18 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

  • Diarrhoea (named in the label)83
  • Clostridium Difficile Infection57
  • Drug Ineffective (a use or a product term, not a reaction)21
  • Clostridium Test Positive20
  • Pyrexia18
  • Abdominal Pain (named in the label)14
  • Nausea (named in the label)14
  • Abdominal Distension (named in the label)11

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Donor human stool side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other