Donor human stool spores (ethanol treated)

FDA label, Aimmune Therapeutics, Inc., oral, effective 2026-04-23. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

2 DOSAGE AND ADMINISTRATION For oral administration only. Prior to taking the first dose: Complete antibacterial treatment for rCDI 2 to 4 days before initiating treatment with VOWST. Drink 296 mL (10 oz) of magnesium citrate on the day before and at least 8 hours prior to taking the first dose of VOWST. In clinical studies, participants with impaired kidney function received polyethylene glycol electrolyte solution (250 mL GoLYTELY, not approved for this use).

In clinical studies, participants with impaired kidney function received polyethylene glycol electrolyte solution (250 mL GoLYTELY, not approved for this use) [see Clinical Studies ]. Do not eat or drink, except for small amount of water, for at least 8 hours prior to taking the first dose. 2.2 Dosing regimen The dosage of VOWST is 4 capsules taken orally once daily for 3 consecutive days.

Drug interactions

Check donor human stool spores (ethanol treated) against a medication list
Label text (1 paragraph)

7 DRUG INTERACTIONS VOWST contains bacterial spores; therefore, antibacterials should not be administered concurrently with VOWST. Antibacterials should not be administered concurrently with VOWST. ( 7 )

Contraindications

None . None. ( 4 )

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for donor human stool spores (ethanol treated). Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no data on use of VOWST in pregnant individuals. Developmental toxicity studies in animals have not been conducted with VOWST.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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Price ladder

Not the price at the counter
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These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

Products and NDCs

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Recruiting clinical trials

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