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Molecule

Donor human stool

Available on requestBiologicCold chain
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Donor human stool is a prescription medicine 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. Limitation of Use. MedsAcross supplies Donor human stool for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

US FDA first approval
Not recorded
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Rectal
Dosage forms
Rectal suspension
Biologic
Yes
Identifiers
UNII 3TVP4E28JR

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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. Limitation of Use: REBYOTA is not indicated for treatment of CDI.

Source: US FDA prescribing information

Dosing overview

For rectal administration only. Administer REBYOTA 24 to 72 hours after the last dose of antibiotics for CDI. Administer a single dose of 150 mL rectally of REBYOTA.

Source: US FDA prescribing information

Contraindications

Do not administer REBYOTA to individuals with a history of a severe allergic reaction (e.g. anaphylaxis) to any of the known product components. Severe allergic reactions (e.g. anaphylaxis) to any component of REBYOTA.

Source: US FDA prescribing information

Warnings and precautions

Transmissible infectious agents Because REBYOTA is manufactured from human fecal matter it may carry a risk of transmitting infectious agents. Any infection suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Ferring Pharmaceuticals Inc.

Source: US FDA prescribing information

Side effects

The most commonly reported (≥ 3%) adverse reactions occurring in adults following a single dose of REBYOTA were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%). The most commonly reported (≥ 3%) adverse reactions occurring in adults following a single dose of REBYOTA were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%) ( Table 1 ).

Source: US FDA prescribing information

Storage

Store the REBYOTA carton in an ultracold freezer (-60°C to -90°C, -76°F to -130°F). Alternatively, store in a refrigerator (2°C to 8°C, 36°F to 46°F) for up to 5 days (including thaw time). Store the administration set at 10°C to 34°C (50°F to 93°F). DO NOT store the administration set in the freezer. Before Using: Prior to use, thaw REBYOTA completely by placing carton in a refrigerator (2°C to 8°C, 36°F to 46°F) for approximately 24 hours.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Donor human stool, sorted by availability.

MedicineManufacturerRegisterAvailability
Rebyota 50000000000 CFU/150 mL rectal suspensionRectal Cold chainFerring PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDANot recorded—
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Donor human stool available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Donor human stool and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Donor human stool have?

The catalogue lists 1 brand names for Donor human stool, including Rebyota.

Does Donor human stool need cold chain shipping?

At least one listed presentation of Donor human stool must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

References

  1. Rebyota prescribing information (Ferring Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 23 December 2024

Request Donor human stool for export supply

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