Saccharomyces Cerevisiae side effects: what 859 FDA adverse event reports show

Saccharomyces Cerevisiae · A-34 · 30 reaction terms · 234 drug–reaction co-reports · data 2026-09-14

Drug class

Non-Standardized Fungal Allergenic Extract, Non-Standardized Food Allergenic Extract

FDA label (Established Pharmacologic Class)

Brand names

A-34

openFDA label

Who reports

859 reports · 77% serious · 105 with death outcome · 62% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Allergies.

FDA label, Indications and Usage

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 19 strongest signals

Reporting / coding artifact 1No label text to screen 18

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 11 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
Covid-19 pneumonia	14	28.7 17.1–48.3ROR 29.2 · χ² 347 / p 8e-78	27.7 EB05 17.5 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.7	no trial data cached
Infusion site pain	15	28.7 17.4–47.4ROR 29.2 · χ² 373 / p 2e-83	27.7 EB05 17.8 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=14	no trial data cached
Tachypnoea	14	25.2 15.0–42.4ROR 25.6 · χ² 302 / p 7e-68	24.4 EB05 15.3 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.3	no trial data cached
Clostridium difficile infection	21	23.6 15.5–36.1ROR 24.2 · χ² 433 / p 2e-96	23.2 EB05 15.9 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.6	no trial data cached
Brain oedema	12	23.2 13.2–40.7ROR 23.5 · χ² 233 / p 7e-53	22.3 EB05 13.3 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.4	no trial data cached
Clostridium difficile colitis	10	23.0 12.4–42.6ROR 23.2 · χ² 189 / p 3e-43	21.8 EB05 12.1 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.4	no trial data cached
Acute respiratory failure	17	21.7 13.5–34.7ROR 22.1 · χ² 315 / p 1e-70	21.1 EB05 13.8 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.2	no trial data cached
Dermatitis contact	8	17.2 8.6–34.3ROR 17.3 · χ² 106 / p 3e-25	15.1 EB05 6.7 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=6	no trial data cached
Brain fog	10	16.7 9.0–31.0ROR 16.9 · χ² 133 / p 6e-31	15.2 EB05 7.7 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.4	no trial data cached
Insurance issue	10	16.4 8.9–30.4ROR 16.6 · χ² 130 / p 2e-30	14.9 EB05 7.5 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.7	no trial data cached
Seasonal allergy	9	15.6 8.1–29.8ROR 15.7 · χ² 108 / p 1e-25	13.6 EB05 6.4 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=8	no trial data cached
Hepatomegaly	6	14.8 6.7–32.9ROR 14.9 · χ² 64 / p 6e-16	11.2 EB05 4.3 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.0	no trial data cached
Oesophagitis	6	13.4 6.0–29.7ROR 13.5 · χ² 57 / p 2e-14	9.8 EB05 3.9 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 11.1	no trial data cached
Hospice care	5	12.4 5.2–29.7ROR 12.4 · χ² 42 / p 6e-11	8.1 EB05 3.1 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.7	no trial data cached
Breast cancer metastatic	5	11.4 4.7–27.2ROR 11.4 · χ² 37 / p 5e-10	7.3 EB05 2.9 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.6	no trial data cached
Localised infection	11	11.1 6.2–19.9ROR 11.2 · χ² 91 / p 7e-22	9.2 EB05 4.9 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 9.7	no trial data cached
Drug level increased	7	10.3 4.9–21.6ROR 10.4 · χ² 50 / p 8e-13	7.4 EB05 3.5 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 8.5	no trial data cached
Hepatic cytolysis	5	10.0 4.2–23.9ROR 10.0 · χ² 32 / p 8e-9	6.3 EB05 2.7 · IC025 +0.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.4	no trial data cached
Prescribed underdose	8	9.8 4.9–19.5ROR 9.9 · χ² 55 / p 7e-14	7.3 EB05 3.6 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.4	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
Clostridium difficile infection	21	23.6 15.5–36.1ROR 24.2 · χ² 433 / p 2e-96	23.2 EB05 15.9 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.6	no trial data cached
Acute respiratory failure	17	21.7 13.5–34.7ROR 22.1 · χ² 315 / p 1e-70	21.1 EB05 13.8 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.2	no trial data cached
Infusion site pain	15	28.7 17.4–47.4ROR 29.2 · χ² 373 / p 2e-83	27.7 EB05 17.8 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=14	no trial data cached
Tachypnoea	14	25.2 15.0–42.4ROR 25.6 · χ² 302 / p 7e-68	24.4 EB05 15.3 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.3	no trial data cached
Covid-19 pneumonia	14	28.7 17.1–48.3ROR 29.2 · χ² 347 / p 8e-78	27.7 EB05 17.5 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.7	no trial data cached
Brain oedema	12	23.2 13.2–40.7ROR 23.5 · χ² 233 / p 7e-53	22.3 EB05 13.3 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.4	no trial data cached
Localised infection	11	11.1 6.2–19.9ROR 11.2 · χ² 91 / p 7e-22	9.2 EB05 4.9 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 9.7	no trial data cached
Insurance issue	10	16.4 8.9–30.4ROR 16.6 · χ² 130 / p 2e-30	14.9 EB05 7.5 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.7	no trial data cached
Brain fog	10	16.7 9.0–31.0ROR 16.9 · χ² 133 / p 6e-31	15.2 EB05 7.7 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.4	no trial data cached
Clostridium difficile colitis	10	23.0 12.4–42.6ROR 23.2 · χ² 189 / p 3e-43	21.8 EB05 12.1 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.4	no trial data cached
Seasonal allergy	9	15.6 8.1–29.8ROR 15.7 · χ² 108 / p 1e-25	13.6 EB05 6.4 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=8	no trial data cached
Prescribed underdose	8	9.8 4.9–19.5ROR 9.9 · χ² 55 / p 7e-14	7.3 EB05 3.6 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.4	no trial data cached
Dermatitis contact	8	17.2 8.6–34.3ROR 17.3 · χ² 106 / p 3e-25	15.1 EB05 6.7 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=6	no trial data cached
Drug level increased	7	10.3 4.9–21.6ROR 10.4 · χ² 50 / p 8e-13	7.4 EB05 3.5 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 8.5	no trial data cached
Oesophagitis	6	13.4 6.0–29.7ROR 13.5 · χ² 57 / p 2e-14	9.8 EB05 3.9 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 11.1	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 Saccharomyces Cerevisiae?

In FDA FAERS, the most frequently co-reported reaction terms for Saccharomyces Cerevisiae are clostridium difficile infection, acute respiratory failure, infusion site pain, tachypnoea, covid-19 pneumonia, brain oedema. 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 Saccharomyces Cerevisiae have an FDA boxed warning?

No. The FDA label retrieved for Saccharomyces Cerevisiae has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Saccharomyces Cerevisiae 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 68dced34-b0eb-4baa-be65-ecd881ab19c5, effective 20250109; matched on openfda.generic_name.exact:"SACCHAROMYCES CEREVISIAE")
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, 30 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.