Drug · FAERS side-effect profile with label screen
Bismuth side effects: what 395 FDA adverse event reports show
Drug class
Bismuth
FDA label (Established Pharmacologic Class)
Who reports
395 reports · 88% serious · 106 with death outcome · 40% female
openFDA FAERS counts, all years, deduplication not applied
Used for
relieves Traveler's diarrhea Diarrhea Upset stomach due to overindulgence in food and drink, including Heartburn Indigestion Nausea Gas Belching Fullness
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 27 strongest signals
Reporting / coding artifact 3Lab value / disease marker 1No label text to screen 23
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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 9 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Appendicitis | 59 | 339.1 267.7–429.4ROR 398.4 · χ² 19,434 / p <1e-300 | 303.7 EB05 244.1 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 224.6 · ♀ 0% (drug 40%) · 98% clinician | no trial data cached |
| Ventricular fibrillation | 58 | 277.9 218.9–352.7ROR 325.5 · χ² 15,651 / p <1e-300 | 253.4 EB05 203.2 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 182.0 · ♀ 0% (drug 40%) · 98% clinician | no trial data cached |
| Cardiogenic shock | 55 | 205.4 160.6–262.6ROR 238.5 · χ² 10,948 / p <1e-300 | 191.1 EB05 152.3 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 134.3 · ♀ 0% (drug 40%) · 98% clinician | no trial data cached |
| Bacterial infection | 48 | 137.5 105.5–179.4ROR 156.4 · χ² 6,360 / p <1e-300 | 130.2 EB05 102.1 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 104.2 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 64 | 122.0 97.5–152.8ROR 145.4 · χ² 7,554 / p <1e-300 | 117.6 EB05 95.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 79.9 · ♀ 0% (drug 40%) · 98% clinician | no trial data cached |
| Ascites | 66 | 119.4 95.8–148.8ROR 143.1 · χ² 7,622 / p <1e-300 | 115.2 EB05 93.7 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 79.4 · ♀ 2% (drug 40%) · 98% clinician | no trial data cached |
| Neuralgia | 49 | 107.5 82.7–139.7ROR 122.5 · χ² 5,058 / p <1e-300 | 103.0 EB05 81.0 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 104.6 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Incorrect route of product administration | 32 | 101.3 72.6–141.2ROR 110.1 · χ² 3,074 / p <1e-300 | 95.5 EB05 70.8 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 132.7 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Cytopenia | 14 | 62.3 37.2–104.2ROR 64.5 · χ² 783 / p 1e-172 | 57.6 EB05 36.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.2 | no trial data cached |
| Hyperlipidaemia | 14 | 62.1 37.1–103.9ROR 64.3 · χ² 781 / p 4e-172 | 57.4 EB05 36.3 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.9 | no trial data cached |
| Hyponatraemia (low sodium) | 65 | 61.5 49.2–76.8ROR 73.4 · χ² 3,811 / p <1e-300 | 60.4 EB05 49.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.4 · ♀ 0% (drug 40%) · 98% clinician | no trial data cached |
| Blood cholesterol increased | 52 | 59.3 46.0–76.3ROR 68.1 · χ² 2,923 / p <1e-300 | 58.0 EB05 45.9 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious PRR 59.0 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Clostridium difficile colitis | 10 | 50.0 27.1–92.3ROR 51.3 · χ² 433 / p 2e-96 | 45.9 EB05 26.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.5 | no trial data cached |
| Chronic obstructive pulmonary disease | 43 | 43.8 33.0–58.1ROR 49.0 · χ² 1,759 / p <1e-300 | 43.0 EB05 33.3 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.6 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Ulcer | 13 | 43.3 25.4–74.0ROR 44.8 · χ² 496 / p 3e-110 | 40.9 EB05 25.4 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.9 | no trial data cached |
| Stress | 58 | 42.8 33.8–54.3ROR 50.0 · χ² 2,335 / p <1e-300 | 42.3 EB05 33.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.7 · ♀ 0% (drug 40%) · 98% clinician | no trial data cached |
| Drug eruption | 14 | 42.2 25.2–70.6ROR 43.7 · χ² 523 / p 6e-116 | 40.1 EB05 25.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.9 | no trial data cached |
| Gout | 14 | 41.4 24.7–69.3ROR 42.9 · χ² 512 / p 1e-113 | 39.3 EB05 24.9 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.1 | no trial data cached |
| End stage renal disease | 14 | 40.4 24.1–67.6ROR 41.8 · χ² 499 / p 8e-111 | 38.4 EB05 24.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.5 | no trial data cached |
| Dry mouth | 58 | 38.0 30.0–48.3ROR 44.4 · χ² 2,062 / p <1e-300 | 37.6 EB05 30.1 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.6 · ♀ 2% (drug 40%) · 97% clinician | no trial data cached |
| Blood test abnormal | 10 | 37.8 20.5–69.8ROR 38.8 · χ² 323 / p 2e-72 | 35.5 EB05 20.5 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 38.0 | no trial data cached |
| Diabetes mellitus | 50 | 34.7 26.8–44.9ROR 39.6 · χ² 1,607 / p <1e-300 | 34.3 EB05 27.0 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.7 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Abdominal distension (bloating) | 66 | 33.7 27.1–42.0ROR 40.3 · χ² 2,072 / p <1e-300 | 33.4 EB05 27.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.5 · ♀ 5% (drug 40%) · 98% clinician | no trial data cached |
| Thrombosis | 51 | 33.6 26.0–43.4ROR 38.4 · χ² 1,585 / p <1e-300 | 33.2 EB05 26.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.9 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Intentional product misuse | 46 | 28.1 21.4–36.9ROR 31.7 · χ² 1,181 / p 5e-259 | 27.8 EB05 21.7 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 42.0 · ♀ 2% (drug 40%) · 100% clinician | no trial data cached |
| Swelling | 49 | 27.9 21.4–36.2ROR 31.7 · χ² 1,247 / p 1e-273 | 27.6 EB05 21.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.7 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 50 | 27.8 21.5–36.0ROR 31.7 · χ² 1,271 / p 1e-278 | 27.5 EB05 21.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.4 · ♀ 4% (drug 40%) · 98% clinician | 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 |
|---|---|---|---|---|---|---|
| Abdominal distension (bloating) | 66 | 33.7 27.1–42.0ROR 40.3 · χ² 2,072 / p <1e-300 | 33.4 EB05 27.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.5 · ♀ 5% (drug 40%) · 98% clinician | no trial data cached |
| Ascites | 66 | 119.4 95.8–148.8ROR 143.1 · χ² 7,622 / p <1e-300 | 115.2 EB05 93.7 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 79.4 · ♀ 2% (drug 40%) · 98% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 65 | 61.5 49.2–76.8ROR 73.4 · χ² 3,811 / p <1e-300 | 60.4 EB05 49.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.4 · ♀ 0% (drug 40%) · 98% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 64 | 122.0 97.5–152.8ROR 145.4 · χ² 7,554 / p <1e-300 | 117.6 EB05 95.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 79.9 · ♀ 0% (drug 40%) · 98% clinician | no trial data cached |
| Appendicitis | 59 | 339.1 267.7–429.4ROR 398.4 · χ² 19,434 / p <1e-300 | 303.7 EB05 244.1 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 224.6 · ♀ 0% (drug 40%) · 98% clinician | no trial data cached |
| Dry mouth | 58 | 38.0 30.0–48.3ROR 44.4 · χ² 2,062 / p <1e-300 | 37.6 EB05 30.1 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.6 · ♀ 2% (drug 40%) · 97% clinician | no trial data cached |
| Stress | 58 | 42.8 33.8–54.3ROR 50.0 · χ² 2,335 / p <1e-300 | 42.3 EB05 33.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.7 · ♀ 0% (drug 40%) · 98% clinician | no trial data cached |
| Ventricular fibrillation | 58 | 277.9 218.9–352.7ROR 325.5 · χ² 15,651 / p <1e-300 | 253.4 EB05 203.2 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 182.0 · ♀ 0% (drug 40%) · 98% clinician | no trial data cached |
| Cardiogenic shock | 55 | 205.4 160.6–262.6ROR 238.5 · χ² 10,948 / p <1e-300 | 191.1 EB05 152.3 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 134.3 · ♀ 0% (drug 40%) · 98% clinician | no trial data cached |
| Blood cholesterol increased | 52 | 59.3 46.0–76.3ROR 68.1 · χ² 2,923 / p <1e-300 | 58.0 EB05 45.9 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious PRR 59.0 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Thrombosis | 51 | 33.6 26.0–43.4ROR 38.4 · χ² 1,585 / p <1e-300 | 33.2 EB05 26.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.9 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 50 | 27.8 21.5–36.0ROR 31.7 · χ² 1,271 / p 1e-278 | 27.5 EB05 21.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.4 · ♀ 4% (drug 40%) · 98% clinician | no trial data cached |
| Diabetes mellitus | 50 | 34.7 26.8–44.9ROR 39.6 · χ² 1,607 / p <1e-300 | 34.3 EB05 27.0 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.7 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Swelling | 49 | 27.9 21.4–36.2ROR 31.7 · χ² 1,247 / p 1e-273 | 27.6 EB05 21.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.7 · ♀ 0% (drug 40%) · 100% clinician | no trial data cached |
| Neuralgia | 49 | 107.5 82.7–139.7ROR 122.5 · χ² 5,058 / p <1e-300 | 103.0 EB05 81.0 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 104.6 · ♀ 0% (drug 40%) · 100% clinician | 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 Bismuth?
In FDA FAERS, the most frequently co-reported reaction terms for Bismuth are abdominal distension, ascites, hyponatraemia, multiple organ dysfunction syndrome, appendicitis, dry mouth. 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 Bismuth have an FDA boxed warning?
No. The FDA label retrieved for Bismuth has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Bismuth 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 26a65c79-3bc1-a424-e063-6394a90a848e, effective 20251218; matched on
openfda.generic_name.exact:"BISMUTH") - 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, fieldpatient.drug.openfda.generic_name.exact, 36 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.