Saccharomyces boulardii
Pronunciation: sak-uh-roh-MY-seez boo-LAR-dee-eye.
- Generic name
- Saccharomyces cerevisiae var. boulardii (strains CNCM I-745 / CNCM I-1079)
- Drug class
- Probiotic yeast (non-pathogenic, non-bacterial probiotic)
- Form
- Capsule, oral powder/sachet for suspension
- Route
- Oral
- Legal status
- Regulatory status varies by country: a licensed medicine (prescription/pharmacy medicine framework) in France; a licensed Natural Health Product in Canada; a TGA-listed complementary medicine in Australia; and an unlicensed over-the-counter food/dietary supplement in the United States and United Kingdom. Always check the actual product label in your own country.
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: GastroHealth Gut Function & Care Gastro SB Probiotics (5), SB Floraid (5) · Full directory
What Saccharomyces cerevisiae var. boulardii (strains CNCM I-745 / CNCM I-1079) is and how it works
Saccharomyces boulardii is a probiotic ("friendly") yeast taken by mouth to help support or restore the normal balance of microorganisms in the gut, most often used to help reduce diarrhoea, including diarrhoea that can occur alongside antibiotic treatment. (2) (3) (1)
How this product is regulated is genuinely different from country to country -- in France it is a licensed medicine with its own product label; in the US and UK it is sold as a food/dietary supplement that has not been evaluated by the medicines regulator for safety or effectiveness in the way a licensed medicine is. Regardless of which category applies where you live, there is a real and serious safety issue to know about: rare but genuine cases of the yeast entering the bloodstream (fungaemia) have been reported in critically ill or immunocompromised patients, and in patients with a central line (central venous catheter) -- this product should not be used in those situations. Always tell your clinician you are taking (or considering) this product, especially if you are seriously unwell, immunocompromised, or have any kind of central line or catheter in place.
Mechanism of action: how Saccharomyces cerevisiae var. boulardii (strains CNCM I-745 / CNCM I-1079) works
Saccharomyces boulardii is a non-pathogenic probiotic yeast, taxonomically a strain of Saccharomyces cerevisiae, thought to act within the gut lumen to help normalise gut flora and reduce pathogen-associated diarrhoea; it is not systemically absorbed under normal conditions, which is why bloodstream entry (fungaemia) is a rare event specifically associated with critical illness, immunosuppression, or a breach such as a central venous catheter. (2) (3)
What Saccharomyces cerevisiae var. boulardii (strains CNCM I-745 / CNCM I-1079) is used for
Diarrhoea, including antibiotic-associated diarrhoea
Used as an adjunctive (add-on) treatment for diarrhoea, alongside appropriate rehydration, in adults and children 6 years and older, under the licensed-medicine framework confirmed in France. In countries where it is sold as a supplement, similar traditional/general use for gut-flora and digestive support is the basis for sale, without a regulator-evaluated disease claim. (2)
General digestive/gut-flora support (supplement-category markets)
In the United States and United Kingdom, where this product is sold as a food/dietary supplement rather than an approved medicine, it is marketed generally for digestive and gut-flora support rather than for a specific evaluated disease indication. (1) (6)
Before taking Saccharomyces cerevisiae var. boulardii (strains CNCM I-745 / CNCM I-1079)
Do not take / not appropriate for
- Do not take Saccharomyces boulardii if you are critically ill or have a seriously weakened immune system (immunocompromised) -- rare but genuine, sometimes fatal, cases of the yeast entering the bloodstream (fungaemia) have occurred in these groups. (all countries) (2) (3)
- Do not take Saccharomyces boulardii if you have a central venous catheter (a central line) in place. (all countries) (2)
- Do not take it if you have a known allergy or hypersensitivity to it, or have had an allergic reaction to a previous dose. (all countries) (1)
Tell your clinician about
- Whether you are currently critically ill, hospitalised in intensive care, or have a weakened immune system for any reason (e.g. cancer treatment, organ transplant, HIV with low immune counts).
- Whether you have a central venous catheter or any other indwelling vascular line.
- Whether you are pregnant, breastfeeding, or considering giving this product to a young child.
- All other medicines and supplements you take, including any antifungal medicines.
How to take Saccharomyces cerevisiae var. boulardii (strains CNCM I-745 / CNCM I-1079)
- Follow the dose on your specific product's label, or the dose recommended by the clinician or pharmacist who suggested it, since labelled directions differ between the licensed-medicine version (France) and supplement-labelled versions (US, UK, and elsewhere).
- Capsules are usually swallowed whole with water; powder/sachet forms are usually mixed with a small amount of water, milk, or food just before taking, following the specific product's instructions.
- Because this product contains live yeast, avoid handling it with wet hands, and take particular care with hygiene if you are preparing it for someone in a hospital setting.
- Do not give this product to anyone who is critically ill, immunocompromised, or who has a central venous catheter.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)
Missed dose
If you miss a dose, take the next one at its usual time. do not take an extra dose doses. If you are using this product as directed by a clinician for a specific condition, follow their guidance on missed doses.
Overdose
Significant overdose with this probiotic yeast product is not well documented in the sources reviewed for this dossier. If you experience persistent digestive symptoms, fever, or feel seriously unwell after taking a larger amount than directed, contact a pharmacist, clinician, or poison control service for guidance. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Mild bloating, gas, or general digestive discomfort, particularly when starting the product.
What to notice: Mild bloating, gas, or general digestive discomfort, particularly when starting the product.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Allergic sensitisation has been reported with oral use in some people.
What to notice: Allergic sensitisation has been reported with oral use in some people.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Serious warnings
Signs of fungaemia (yeast infection in the bloodstream) — regulator_confirmed_serious_warning
Symptoms: New fever, chills, low blood pressure, rapid heartbeat, or feeling suddenly and seriously unwell, especially in a hospital or intensive-care setting, or in a person with a weakened immune system or a central venous catheter.
Action: This is a real, EU-regulator-confirmed risk (French ANSM safety communication and the EU/CMDh's 2017 EU-wide safety review): rare cases of Saccharomyces boulardii entering the bloodstream have been reported in critically ill or immunocompromised patients, some with a fatal outcome. This product is now contraindicated in critically ill patients, immunocompromised patients, and anyone with a central venous catheter. Seek immediate medical attention for any of these symptoms in a person who has recently taken this product in a hospital or high-risk setting. (2) (3)
Signs of a serious allergic reaction — emergency
Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives.
Action: Seek emergency medical help immediately, and let the clinician you see advise on whether to continue or stop the product. (1)
Interactions
- Antifungal medicines (such as itraconazole) can reduce the number of live Saccharomyces boulardii organisms and may reduce this product's effect; colonisation has been shown to decrease during and for about 2 weeks after itraconazole treatment. (7)
- As a live-organism product, it should not be combined with use in patients receiving treatment in a way that could introduce it into the bloodstream (e.g. via a central venous catheter) -- see serious warnings. (2)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Sources reviewed for this dossier do not establish specific safety data for pregnancy; US supplement labelling advises asking a health professional before use if pregnant. (1) (2) (3) (4) (5) (6) (7)
Breastfeeding
Sources reviewed do not establish specific breastfeeding safety data; US supplement labelling advises asking a health professional before use if nursing. (1) (2) (3) (4) (5) (6) (7)
Children
Used in France's licensed-medicine framework in children 6 years and older for the diarrhoea indication; supplement-labelled products in other countries generally direct parents to consult a health professional before giving this product to a child. (1) (2) (3) (4) (5) (6) (7)
Elderly
No specific age-related dose adjustment identified in the sources reviewed; the fungaemia/critical-illness contraindication is the dominant safety consideration for any frail or hospitalised older adult. (1) (2) (3) (4) (5) (6) (7)
Immunocompromised_or_critically_ill
Contraindicated -- see serious warnings. This is the single most important special-population warning for this product. (1) (2) (3) (4) (5) (6) (7)
Central_venous_catheter
Contraindicated in patients with a central venous catheter in place. (1) (2) (3) (4) (5) (6) (7)
Source_ids
FR-ANSM-ULTRA-LEVURE-AMM-SAFETY-2018,EU-EMA-CMDH-PSUSA-FUNGAEMIA-2017,US-DAILYMED-SACCHAROMYCES-BOULARDII-SUPPLEMENT-2026 (1) (2) (3) (4) (5) (6) (7)
Monitoring
Before starting
- Confirm the person is not critically ill, immunocompromised, or fitted with a central venous catheter before use, especially in a hospital setting.
During treatment
- Watch for new fever, signs of infection, or feeling suddenly unwell, particularly in hospitalised or vulnerable patients.
Storage
Store at room temperature away from moisture and heat, as directed on the specific product's label, out of reach of children.
Professional information
Clinician-facing context only, sourced from the French ANSM safety communication, the EU/CMDh 2017 periodic safety review, and the US dietary-supplement label reviewed for this dossier; verify against the specific product's current label before recommending.
France (European Union) -- licensed medicine (Ultra-Levure)
Indication: Adjunctive symptomatic treatment of diarrhoea
Dose summary: Per licensed product strength (50 mg, 100 mg oral suspension powder, or 200 mg capsule), adults and children 6 years and older, alongside rehydration.
Renal context: Not specifically addressed in the sources reviewed. (2)
United States -- dietary supplement (not an FDA-evaluated drug indication)
Indication: General digestive/gut-flora support (supplement claim, not a treated-disease claim)
Dose summary: Label example: 2 capsules (250 mg each) by mouth 1-2 times daily.
Renal context: Not addressed in the sources reviewed. (1)
Hepatic guidance
Not specifically addressed in the sources reviewed for this dossier.
Overdose note
No specific antidote; the primary real safety concern is not overdose but fungaemia risk in critically ill, immunocompromised, or catheterised patients -- see serious warnings. (2) (3)
Frequently asked questions
Is Saccharomyces boulardii a medicine or a supplement?
It depends on the country. In France it is a licensed medicine (Ultra-Levure) with its own regulator-approved product label for treating diarrhoea. In the United States and United Kingdom, it is sold as a food/dietary supplement that has not been evaluated by the medicines regulator for safety or effectiveness the way a licensed medicine is. In Canada it is a licensed Natural Health Product, and in Australia it is a TGA-listed complementary medicine. Always check your own country's product label. (2) (1) (4) (5)
Who should not take Saccharomyces boulardii?
People who are critically ill, have a significantly weakened immune system, or have a central venous catheter (central line) should not take this product, because of a rare but real and sometimes fatal risk of the yeast entering the bloodstream (fungaemia). This is a genuine safety finding confirmed by France's ANSM and the EU's CMDh safety review, not a general precaution. (2) (3)
Can Saccharomyces boulardii be used alongside antibiotics?
It is commonly used alongside antibiotics to help reduce antibiotic-associated diarrhoea, which is one of its traditional/licensed uses. However, since it is a live yeast, it should be taken a few hours apart from antifungal medicines if you are prescribed one, since these can reduce its effect. (2) (7)
What is the mechanism of action of Saccharomyces cerevisiae var. boulardii (strains CNCM I-745 / CNCM I-1079)?
Saccharomyces boulardii is a non-pathogenic probiotic yeast, taxonomically a strain of Saccharomyces cerevisiae, thought to act within the gut lumen to help normalise gut flora and reduce pathogen-associated diarrhoea; it is not systemically absorbed under normal conditions, which is why bloodstream entry (fungaemia) is a rare event specifically associated with critical illness, immunosuppression, or a breach such as a central venous catheter. (2) (3)
References
- SACCHAROMYCES BOULARDII 250 mg capsule -- dietary supplement labelU.S. Food and Drug Administration / DailyMed (NIH) -- dietary supplement label, Krewe Pharma · United States · accessed 2026-07-30 · source 1
- Saccharomyces boulardii (Ultra-Levure) -- ajout d'une contre-indication chez les patients en état critique ou immunodéprimés (safety communication)Agence nationale de sécurité du médicament et des produits de santé (ANSM), France -- national medicines regulator · France (European Union) · accessed 2026-07-30 · source 2
- Saccharomyces boulardii -- CMDh scientific conclusions and grounds for variation of product information (fungaemia risk review)European Medicines Agency (EMA) / Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) -- EU-wide periodic safety update review, PSUSA/00009284/201702 · European Union · accessed 2026-07-30 · source 3
- Saccharomyces boulardii -- Natural Health Product licensing (NPN) statusHealth Canada -- Natural and Non-prescription Health Products Directorate (Natural Health Products licensing, NPN) · Canada · accessed 2026-07-30 · source 4
- Multiple Saccharomyces cerevisiae (Boulardii)-containing products -- ARTG listed (AUST L) complementary medicinesTherapeutic Goods Administration (TGA), Australia -- Australian Register of Therapeutic Goods (ARTG) · Australia · accessed 2026-07-30 · source 5
- Saccharomyces boulardii -- consistently sold as an unlicensed food supplement in the UK; no MHRA/EMC-licensed medicinal product identifiedCross-referenced UK retailer listings (Nutri-Link, Supplement Hub, Optibac, Metagenics UK, Bio-Kult) plus NHS Specialist Pharmacy Service general food-supplement guidance · United Kingdom · accessed 2026-07-30 · source 6
- Saccharomyces boulardii -- no dedicated Medsafe-approved medicine data sheet found; sold over-the-counter as a supplementSearch across Medsafe (New Zealand regulator) indexed pages and NZ retailer listings · New Zealand · accessed 2026-07-30 · source 7
Brand names by country
Single-ingredient Saccharomyces cerevisiae var. boulardii (strains CNCM I-745 / CNCM I-1079) names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
United Kingdom
Canada
- Various Health Canada NPN-licensed Saccharomyces boulardii products (4)Health Canada NHP NPN licensed confirmed · varies by product · Multiple licensed natural health product companies
Australia
New Zealand
- NOW Saccharomyces Boulardii (imported/retail supplement listing) (7)unable to verify dedicated medsafe record · not specified in source · not specified in source
View brands in additional countries.
European Union
Ultra-Levure (France) (2)