Drug · FAERS side-effect profile with label screen

Fecal Microbiota Spores and Live-Brpk side effects: what 1,162 FDA adverse event reports show

Fecal Microbiota Spores, Live-Brpk · 11 reaction terms · 1,088 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Fecal Microbiota Spores, Live-Brpk (Vowst)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,162 reports · 41% serious · 13 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI). VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).

FDA label, Indications and Usage

What it is

VOWST (fecal microbiota spores, live-brpk) is a bacterial spore suspension in capsules for oral administration. VOWST is manufactured from human fecal matter sourced from qualified donors. Human fecal matter donations are routinely tested for a panel of transmissible pathogens.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 9 strongest signals

Labeled adverse reaction 3Likely indication confounding 2Reporting / coding artifact 1Not in label — unassessed 3

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Clostridium difficile infection	327	276.2 251.7–303.1ROR 383.9 · χ² 88,130 / p <1e-300	267.8 EB05 244.3 · IC025 +7.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 404.9	no trial data cached
Clostridium difficile colitis	24	40.8 27.5–60.7ROR 41.7 · χ² 892 / p 3e-196	39.6 EB05 28.0 · IC025 +3.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 59.1	no trial data cached
Flatulence (gas)	61	19.5 15.2–24.8ROR 20.5 · χ² 1,051 / p 7e-231	19.3 EB05 15.6 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.8	no trial data cached
Diarrhoea haemorrhagic	9	17.3 9.0–33.3ROR 17.5 · χ² 123 / p 8e-29	15.6 EB05 7.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 23.5	no trial data cached
Diarrhoea (diarrhea)	549	15.4 14.5–16.4ROR 28.3 · χ² 7,606 / p <1e-300	15.4 EB05 14.3 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.1	no trial data cached
Faeces discoloured	18	15.0 9.5–23.7ROR 15.2 · χ² 221 / p 3e-50	14.3 EB05 9.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.8	no trial data cached
Abdominal distension (bloating)	74	12.8 10.3–16.0ROR 13.6 · χ² 800 / p 3e-176	12.7 EB05 10.4 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.7	no trial data cached
Product use complaint	7	8.1 3.9–17.1ROR 8.2 · χ² 37 / p 6e-10	5.8 EB05 2.9 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Frequent bowel movements	12	8.0 4.6–14.1ROR 8.1 · χ² 67 / p 1e-16	6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.9	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Diarrhoea (diarrhea)	549	15.4 14.5–16.4ROR 28.3 · χ² 7,606 / p <1e-300	15.4 EB05 14.3 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.1	no trial data cached
Clostridium difficile infection	327	276.2 251.7–303.1ROR 383.9 · χ² 88,130 / p <1e-300	267.8 EB05 244.3 · IC025 +7.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 404.9	no trial data cached
Abdominal distension (bloating)	74	12.8 10.3–16.0ROR 13.6 · χ² 800 / p 3e-176	12.7 EB05 10.4 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.7	no trial data cached
Flatulence (gas)	61	19.5 15.2–24.8ROR 20.5 · χ² 1,051 / p 7e-231	19.3 EB05 15.6 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.8	no trial data cached
Clostridium difficile colitis	24	40.8 27.5–60.7ROR 41.7 · χ² 892 / p 3e-196	39.6 EB05 28.0 · IC025 +3.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 59.1	no trial data cached
Faeces discoloured	18	15.0 9.5–23.7ROR 15.2 · χ² 221 / p 3e-50	14.3 EB05 9.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.8	no trial data cached
Frequent bowel movements	12	8.0 4.6–14.1ROR 8.1 · χ² 67 / p 1e-16	6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.9	no trial data cached
Diarrhoea haemorrhagic	9	17.3 9.0–33.3ROR 17.5 · χ² 123 / p 8e-29	15.6 EB05 7.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 23.5	no trial data cached
Product use complaint	7	8.1 3.9–17.1ROR 8.2 · χ² 37 / p 6e-10	5.8 EB05 2.9 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Product physical issue	4	3.6 1.4–9.6ROR 3.6 · χ² 5 / p 0.011	2.8 EB05 1.3 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious n=1	no trial data cached
Product packaging quantity issue	3	5.0 1.6–15.3ROR 5.0 · χ² 6 / p 0.007	3.2 EB05 1.3 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious n=1	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Fecal Microbiota Spores and Live-Brpk?

In FDA FAERS, the most frequently co-reported reaction terms for Fecal Microbiota Spores and Live-Brpk are diarrhoea, clostridium difficile infection, abdominal distension, flatulence, clostridium difficile colitis, faeces discoloured. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Fecal Microbiota Spores and Live-Brpk have an FDA boxed warning?

No. The FDA label retrieved for Fecal Microbiota Spores and Live-Brpk has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Fecal Microbiota Spores and Live-Brpk causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 99e5a37a-930c-4641-bcdd-7013ec1c15fe, effective 20260423; matched on openfda.generic_name.exact:"FECAL MICROBIOTA SPORES, LIVE-BRPK")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 11 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.