Drug · FAERS side-effect profile with label screen
Bismuth Subsalicylate side effects: what 5,768 FDA adverse event reports show
Drug class
Bismuth
FDA label (Established Pharmacologic Class)
Brand names
Pepto-Bismol
openFDA label
Who reports
5,768 reports · 71% serious · 557 with death outcome · 62% female
openFDA FAERS counts, all years, deduplication not applied
Used for
relieves travelers' 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 40 strongest signals
Reporting / coding artifact 1No label text to screen 39
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. 433 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 |
|---|---|---|---|---|---|---|
| End stage renal disease | 467 | 94.5 86.5–103.2ROR 102.7 · χ² 42,025 / p <1e-300 | 91.7 EB05 85.0 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 74.3 | no trial data cached |
| Chronic kidney disease | 1,418 | 68.4 65.4–71.7ROR 90.4 · χ² 92,747 / p <1e-300 | 67.1 EB05 64.2 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.1 | no trial data cached |
| Renal injury | 327 | 40.0 36.0–44.5ROR 42.3 · χ² 12,272 / p <1e-300 | 39.5 EB05 36.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.0 | no trial data cached |
| Appendicitis | 85 | 33.5 27.1–41.4ROR 34.0 · χ² 2,625 / p <1e-300 | 33.0 EB05 27.5 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.2 · ♀ 3% (drug 62%) · 94% clinician | no trial data cached |
| Vitamin d deficiency | 84 | 31.6 25.5–39.1ROR 32.0 · χ² 2,435 / p <1e-300 | 31.1 EB05 25.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.6 | no trial data cached |
| Multiple fractures | 128 | 28.3 23.8–33.6ROR 28.9 · χ² 3,315 / p <1e-300 | 27.9 EB05 24.1 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.7 | no trial data cached |
| Ventricular fibrillation | 86 | 28.3 22.9–34.9ROR 28.7 · χ² 2,217 / p <1e-300 | 27.9 EB05 23.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.7 · ♀ 0% (drug 62%) · 98% clinician | no trial data cached |
| Bone disorder | 125 | 24.9 20.9–29.6ROR 25.4 · χ² 2,822 / p <1e-300 | 24.6 EB05 21.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.0 | no trial data cached |
| Faeces discoloured | 144 | 24.3 20.7–28.5ROR 24.9 · χ² 3,173 / p <1e-300 | 24.1 EB05 20.9 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.9 · 82% consumer | no trial data cached |
| Nephropathy | 62 | 24.1 18.8–31.0ROR 24.4 · χ² 1,344 / p 2e-294 | 23.8 EB05 19.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.7 | no trial data cached |
| Tubulointerstitial nephritis | 116 | 22.6 18.9–27.1ROR 23.1 · χ² 2,363 / p <1e-300 | 22.4 EB05 19.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.2 | no trial data cached |
| Osteoporosis | 233 | 20.7 18.2–23.4ROR 21.5 · χ² 4,323 / p <1e-300 | 20.5 EB05 18.4 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.6 | no trial data cached |
| Cardiogenic shock | 79 | 20.2 16.2–25.2ROR 20.5 · χ² 1,416 / p <1e-300 | 20.0 EB05 16.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.2 · ♀ 3% (drug 62%) · 96% clinician | no trial data cached |
| Renal failure (kidney failure) | 725 | 19.8 18.5–21.2ROR 22.5 · χ² 12,923 / p <1e-300 | 19.7 EB05 18.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.0 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 822 | 19.7 18.5–21.0ROR 22.8 · χ² 14,601 / p <1e-300 | 19.6 EB05 18.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.9 | no trial data cached |
| Intervertebral disc degeneration | 47 | 18.4 13.9–24.5ROR 18.6 · χ² 754 / p 3e-166 | 18.2 EB05 14.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.3 | no trial data cached |
| Osteopenia | 62 | 14.8 11.6–19.0ROR 15.0 · χ² 782 / p 2e-172 | 14.6 EB05 11.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.5 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 312 | 14.2 12.7–15.8ROR 14.9 · χ² 3,809 / p <1e-300 | 14.1 EB05 12.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.5 | no trial data cached |
| Impaired gastric emptying | 47 | 13.4 10.1–17.9ROR 13.5 · χ² 527 / p 7e-117 | 13.2 EB05 10.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.9 · 94% consumer | no trial data cached |
| Foot fracture | 70 | 13.4 10.6–16.9ROR 13.6 · χ² 790 / p 5e-174 | 13.2 EB05 10.8 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.1 · ♀ 88% (drug 62%) | no trial data cached |
| Bacterial infection | 65 | 12.8 10.0–16.2ROR 12.9 · χ² 690 / p 2e-152 | 12.5 EB05 10.1 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 · ♀ 5% (drug 62%) · 91% clinician | no trial data cached |
| Hyperlipidaemia | 41 | 12.5 9.2–16.9ROR 12.5 · χ² 420 / p 1e-93 | 12.1 EB05 9.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.1 · ♀ 18% (drug 62%) | no trial data cached |
| Ascites | 100 | 12.4 10.2–15.0ROR 12.6 · χ² 1,033 / p 6e-227 | 12.2 EB05 10.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.1 · ♀ 7% (drug 62%) · 93% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 94 | 12.3 10.0–15.0ROR 12.5 · χ² 960 / p 5e-211 | 12.1 EB05 10.1 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 · ♀ 6% (drug 62%) · 95% clinician | no trial data cached |
| Wrist fracture | 40 | 12.2 8.9–16.6ROR 12.2 · χ² 397 / p 1e-88 | 11.8 EB05 8.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.2 · ♀ 87% (drug 62%) | no trial data cached |
| Neuralgia | 80 | 12.0 9.7–14.9ROR 12.2 · χ² 795 / p 3e-175 | 11.8 EB05 9.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.7 · ♀ 16% (drug 62%) | no trial data cached |
| Ankle fracture | 50 | 11.7 8.9–15.5ROR 11.8 · χ² 480 / p 1e-106 | 11.4 EB05 8.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 · ♀ 84% (drug 62%) | no trial data cached |
| Incorrect route of product administration | 49 | 10.6 8.0–14.0ROR 10.7 · χ² 416 / p 8e-93 | 10.2 EB05 7.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 16.8 · ♀ 0% (drug 62%) · 100% clinician | no trial data cached |
| Gout | 48 | 9.7 7.3–12.9ROR 9.8 · χ² 366 / p 6e-82 | 9.3 EB05 7.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 · ♀ 27% (drug 62%) | no trial data cached |
| Renal tubular necrosis | 26 | 9.6 6.6–14.1ROR 9.7 · χ² 192 / p 6e-44 | 8.8 EB05 6.1 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 | no trial data cached |
| Ulcer | 39 | 8.9 6.5–12.2ROR 9.0 · χ² 265 / p 5e-60 | 8.3 EB05 6.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 · ♀ 17% (drug 62%) | no trial data cached |
| Gallbladder disorder | 43 | 8.7 6.5–11.8ROR 8.8 · χ² 287 / p 1e-64 | 8.2 EB05 6.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 | no trial data cached |
| Chronic obstructive pulmonary disease | 117 | 8.2 6.8–9.8ROR 8.3 · χ² 729 / p 9e-161 | 8.0 EB05 6.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · ♀ 31% (drug 62%) · 92% clinician | no trial data cached |
| Arthritis | 171 | 7.9 6.8–9.2ROR 8.1 · χ² 1,025 / p 4e-225 | 7.8 EB05 6.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 | no trial data cached |
| Lower limb fracture | 39 | 7.4 5.4–10.2ROR 7.5 · χ² 210 / p 6e-48 | 6.9 EB05 5.2 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 · ♀ 85% (drug 62%) | no trial data cached |
| Ligament sprain | 20 | 7.4 4.8–11.4ROR 7.4 · χ² 104 / p 1e-24 | 6.5 EB05 4.4 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial data cached |
| Sputum discoloured | 19 | 7.3 4.7–11.5ROR 7.3 · χ² 97 / p 3e-23 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 | no trial data cached |
| Joint injury | 42 | 7.1 5.3–9.7ROR 7.2 · χ² 216 / p 4e-49 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 | no trial data cached |
| Back disorder | 32 | 7.1 5.0–10.1ROR 7.2 · χ² 162 / p 2e-37 | 6.5 EB05 4.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.0 | no trial data cached |
| Carpal tunnel syndrome | 27 | 7.0 4.8–10.2ROR 7.0 · χ² 133 / p 6e-31 | 6.3 EB05 4.5 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 | 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 |
|---|---|---|---|---|---|---|
| Chronic kidney disease | 1,418 | 68.4 65.4–71.7ROR 90.4 · χ² 92,747 / p <1e-300 | 67.1 EB05 64.2 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.1 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 822 | 19.7 18.5–21.0ROR 22.8 · χ² 14,601 / p <1e-300 | 19.6 EB05 18.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.9 | no trial data cached |
| Diarrhoea (diarrhea) | 756 | 4.3 4.0–4.6ROR 4.8 · χ² 1,949 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.3 | no trial data cached |
| Renal failure (kidney failure) | 725 | 19.8 18.5–21.2ROR 22.5 · χ² 12,923 / p <1e-300 | 19.7 EB05 18.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.0 | no trial data cached |
| Nausea | 654 | 3.0 2.8–3.2ROR 3.3 · χ² 911 / p 2e-200 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial data cached |
| End stage renal disease | 467 | 94.5 86.5–103.2ROR 102.7 · χ² 42,025 / p <1e-300 | 91.7 EB05 85.0 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 74.3 | no trial data cached |
| Vomiting | 434 | 3.4 3.1–3.7ROR 3.6 · χ² 734 / p 5e-162 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial data cached |
| Fatigue (tiredness) | 382 | 1.8 1.6–2.0ROR 1.8 · χ² 136 / p 8e-32 | 1.8 EB05 1.6 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial data cached |
| Renal injury | 327 | 40.0 36.0–44.5ROR 42.3 · χ² 12,272 / p <1e-300 | 39.5 EB05 36.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.0 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 312 | 14.2 12.7–15.8ROR 14.9 · χ² 3,809 / p <1e-300 | 14.1 EB05 12.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.5 | no trial data cached |
| Constipation | 286 | 4.8 4.3–5.4ROR 5.0 · χ² 866 / p 1e-190 | 4.8 EB05 4.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Depression | 280 | 4.5 4.0–5.0ROR 4.6 · χ² 754 / p 3e-166 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 | no trial data cached |
| Abdominal pain | 269 | 4.2 3.7–4.7ROR 4.4 · χ² 661 / p 5e-146 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Abdominal pain upper | 245 | 4.3 3.8–4.9ROR 4.5 · χ² 631 / p 2e-139 | 4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Osteoporosis | 233 | 20.7 18.2–23.4ROR 21.5 · χ² 4,323 / p <1e-300 | 20.5 EB05 18.4 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.6 | 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 Subsalicylate?
In FDA FAERS, the most frequently co-reported reaction terms for Bismuth Subsalicylate are chronic kidney disease, acute kidney injury, diarrhoea, renal failure, nausea, end stage renal disease. 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 Subsalicylate have an FDA boxed warning?
No. The FDA label retrieved for Bismuth Subsalicylate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Bismuth Subsalicylate 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 01b318d2-586d-4953-8f98-addc4e3cd441, effective 20251015; matched on
openfda.generic_name.exact:"BISMUTH SUBSALICYLATE") - 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, 473 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.