Drug · FAERS side-effect profile with label screen
Bismuth Subnitrate side effects: what 134 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Bismuthum Subnitricum
openFDA label
Who reports
134 reports · 100% serious · 125 with death outcome · 2% female
openFDA FAERS counts, all years, deduplication not applied
Used for
See symptoms on front panel. Relieves stomach aches, sour stomach and vomiting
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 5Lab value / disease marker 3No label text to screen 32
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. 8 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 | 64 | 1,084.9 907.7–1,296.6ROR 2,075.8 · χ² 67,777 / p <1e-300 | 813.3 EB05 659.3 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 629.0 · 94% clinician | no trial data cached |
| Ventricular fibrillation | 64 | 904.4 756.9–1,080.6ROR 1,730.3 · χ² 56,551 / p <1e-300 | 707.5 EB05 573.6 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 518.5 · 94% clinician | no trial data cached |
| Hyperlipidaemia | 55 | 721.4 588.4–884.4ROR 1,222.9 · χ² 38,689 / p <1e-300 | 573.8 EB05 457.4 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 455.2 · 95% clinician | no trial data cached |
| Cardiogenic shock | 63 | 693.9 579.3–831.2ROR 1,308.7 · χ² 42,737 / p <1e-300 | 570.4 EB05 461.7 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 397.2 · 94% clinician | no trial data cached |
| Incorrect route of product administration | 73 | 682.7 584.4–797.6ROR 1,498.5 · χ² 48,836 / p <1e-300 | 576.4 EB05 473.7 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious PRR 781.8 · 96% clinician | no trial data cached |
| Bacterial infection | 71 | 600.5 511.6–704.8ROR 1,276.1 · χ² 41,771 / p <1e-300 | 514.8 EB05 421.9 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 397.8 · 94% clinician | no trial data cached |
| Ulcer | 57 | 561.8 461.2–684.4ROR 977.0 · χ² 31,262 / p <1e-300 | 470.9 EB05 376.9 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 406.5 · 95% clinician | no trial data cached |
| Blood test abnormal | 49 | 548.0 438.2–685.4ROR 863.4 · χ² 26,136 / p <1e-300 | 449.8 EB05 353.7 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious PRR 481.3 · 96% clinician | no trial data cached |
| Aspiration | 37 | 536.2 407.4–705.8ROR 740.4 · χ² 19,179 / p <1e-300 | 418.4 EB05 317.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 316.0 · 97% clinician | no trial data cached |
| Hypercholesterolaemia | 31 | 508.6 373.3–693.0ROR 661.4 · χ² 15,159 / p <1e-300 | 385.9 EB05 284.8 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 310.2 · 97% clinician | no trial data cached |
| Gout | 57 | 498.1 408.9–606.7ROR 866.0 · χ² 27,715 / p <1e-300 | 425.3 EB05 340.5 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 431.9 · 96% clinician | no trial data cached |
| Full blood count abnormal | 33 | 491.3 365.1–661.1ROR 651.5 · χ² 15,618 / p <1e-300 | 381.2 EB05 284.0 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious PRR 374.5 · 97% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 87 | 489.4 431.9–554.6ROR 1,393.4 · χ² 41,839 / p <1e-300 | 440.4 EB05 368.1 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 280.5 · 94% clinician | no trial data cached |
| Neuralgia | 75 | 485.4 417.5–564.4ROR 1,101.2 · χ² 35,702 / p <1e-300 | 430.5 EB05 354.8 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 413.6 · 95% clinician | no trial data cached |
| End stage renal disease | 56 | 477.2 390.6–583.0ROR 819.1 · χ² 26,079 / p <1e-300 | 409.0 EB05 326.7 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 273.6 · 95% clinician | no trial data cached |
| Micturition urgency | 33 | 456.8 339.5–614.6ROR 605.7 · χ² 14,521 / p <1e-300 | 360.1 EB05 268.3 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 433.9 · 97% clinician | no trial data cached |
| Ascites | 65 | 346.5 291.0–412.7ROR 672.0 · χ² 22,032 / p <1e-300 | 313.8 EB05 254.8 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 201.9 · 94% clinician | no trial data cached |
| Joint injury | 35 | 256.5 192.9–341.1ROR 346.9 · χ² 8,649 / p <1e-300 | 224.8 EB05 168.9 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 191.3 · 97% clinician | no trial data cached |
| Transaminases increased | 35 | 246.9 185.7–328.4ROR 333.9 · χ² 8,324 / p <1e-300 | 217.4 EB05 163.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 151.5 · 94% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 85 | 237.0 208.4–269.6ROR 646.4 · χ² 19,763 / p <1e-300 | 224.7 EB05 187.4 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 139.7 · 94% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 77 | 231.4 200.0–267.8ROR 542.7 · χ² 17,455 / p <1e-300 | 218.6 EB05 180.6 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 155.3 · 95% clinician | no trial data cached |
| Blood cholesterol increased | 57 | 191.5 157.2–233.2ROR 332.5 · χ² 10,621 / p <1e-300 | 179.8 EB05 143.9 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious PRR 167.0 · 95% clinician | no trial data cached |
| Cardiovascular disorder | 31 | 189.9 139.4–258.6ROR 246.7 · χ² 5,637 / p <1e-300 | 169.9 EB05 125.4 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.5 · 97% clinician | no trial data cached |
| Stress | 86 | 187.3 165.0–212.6ROR 521.2 · χ² 15,788 / p <1e-300 | 179.7 EB05 150.0 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 178.6 · 94% clinician | no trial data cached |
| Coronary artery disease | 36 | 184.8 139.8–244.5ROR 252.4 · χ² 6,401 / p <1e-300 | 168.3 EB05 127.0 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 108.1 · 97% clinician | no trial data cached |
| Lower respiratory tract infection | 50 | 172.8 138.8–215.3ROR 275.1 · χ² 8,380 / p <1e-300 | 162.1 EB05 127.7 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 105.2 · 94% clinician | no trial data cached |
| Sleep disorder | 73 | 163.4 140.0–190.8ROR 357.8 · χ² 11,649 / p <1e-300 | 156.6 EB05 128.7 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 155.0 · 95% clinician | no trial data cached |
| Diabetes mellitus | 78 | 159.6 138.2–184.2ROR 380.4 · χ² 12,163 / p <1e-300 | 153.5 EB05 126.9 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 99.7 · 94% clinician | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 33 | 152.5 113.4–205.2ROR 202.0 · χ² 4,820 / p <1e-300 | 140.2 EB05 104.4 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 89.3 · 97% clinician | no trial data cached |
| Thrombosis | 75 | 145.6 125.3–169.2ROR 329.4 · χ² 10,657 / p <1e-300 | 140.3 EB05 115.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 86.8 · 95% clinician | no trial data cached |
| Intentional product misuse | 74 | 133.4 114.5–155.4ROR 296.8 · χ² 9,626 / p <1e-300 | 128.9 EB05 106.1 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious PRR 174.3 · 95% clinician | no trial data cached |
| Swelling | 76 | 127.5 109.9–147.8ROR 293.2 · χ² 9,443 / p <1e-300 | 123.5 EB05 101.9 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 119.0 · 95% clinician | no trial data cached |
| Drug intolerance | 77 | 125.3 108.3–145.0ROR 293.2 · χ² 9,406 / p <1e-300 | 121.5 EB05 100.4 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious PRR 117.5 · 95% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 75 | 123.0 105.9–143.0ROR 278.2 · χ² 8,990 / p <1e-300 | 119.3 EB05 98.3 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.1 · 95% clinician | no trial data cached |
| Sepsis (blood infection) | 85 | 119.3 104.9–135.7ROR 324.5 · χ² 9,897 / p <1e-300 | 116.1 EB05 96.9 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.0 · 94% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 35 | 118.8 89.3–157.9ROR 160.4 · χ² 3,976 / p <1e-300 | 111.6 EB05 83.9 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 116.3 · 97% clinician | no trial data cached |
| General physical health deterioration | 87 | 118.6 104.7–134.3ROR 336.3 · χ² 10,075 / p <1e-300 | 115.6 EB05 96.6 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious PRR 79.8 · 94% clinician | no trial data cached |
| Dry mouth | 61 | 118.0 98.0–142.0ROR 215.7 · χ² 6,979 / p <1e-300 | 113.7 EB05 91.7 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 134.6 · 95% clinician | no trial data cached |
| Liver function test increased | 16 | 117.5 74.2–186.1ROR 133.3 · χ² 1,734 / p <1e-300 | 103.3 EB05 67.4 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 105.5 | no trial data cached |
| Blood creatinine increased | 49 | 117.3 93.8–146.6ROR 184.3 · χ² 5,547 / p <1e-300 | 112.2 EB05 88.2 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious PRR 77.6 · 94% 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 |
|---|---|---|---|---|---|---|
| General physical health deterioration | 87 | 118.6 104.7–134.3ROR 336.3 · χ² 10,075 / p <1e-300 | 115.6 EB05 96.6 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious PRR 79.8 · 94% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 87 | 489.4 431.9–554.6ROR 1,393.4 · χ² 41,839 / p <1e-300 | 440.4 EB05 368.1 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 280.5 · 94% clinician | no trial data cached |
| Stress | 86 | 187.3 165.0–212.6ROR 521.2 · χ² 15,788 / p <1e-300 | 179.7 EB05 150.0 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 178.6 · 94% clinician | no trial data cached |
| Sepsis (blood infection) | 85 | 119.3 104.9–135.7ROR 324.5 · χ² 9,897 / p <1e-300 | 116.1 EB05 96.9 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.0 · 94% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 85 | 237.0 208.4–269.6ROR 646.4 · χ² 19,763 / p <1e-300 | 224.7 EB05 187.4 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 139.7 · 94% clinician | no trial data cached |
| Diabetes mellitus | 78 | 159.6 138.2–184.2ROR 380.4 · χ² 12,163 / p <1e-300 | 153.5 EB05 126.9 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 99.7 · 94% clinician | no trial data cached |
| Drug hypersensitivity | 77 | 62.1 53.6–71.8ROR 144.6 · χ² 4,606 / p <1e-300 | 61.1 EB05 50.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 99.5 · 95% clinician | no trial data cached |
| Drug intolerance | 77 | 125.3 108.3–145.0ROR 293.2 · χ² 9,406 / p <1e-300 | 121.5 EB05 100.4 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious PRR 117.5 · 95% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 77 | 231.4 200.0–267.8ROR 542.7 · χ² 17,455 / p <1e-300 | 218.6 EB05 180.6 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 155.3 · 95% clinician | no trial data cached |
| Swelling | 76 | 127.5 109.9–147.8ROR 293.2 · χ² 9,443 / p <1e-300 | 123.5 EB05 101.9 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 119.0 · 95% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 75 | 123.0 105.9–143.0ROR 278.2 · χ² 8,990 / p <1e-300 | 119.3 EB05 98.3 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.1 · 95% clinician | no trial data cached |
| Thrombosis | 75 | 145.6 125.3–169.2ROR 329.4 · χ² 10,657 / p <1e-300 | 140.3 EB05 115.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 86.8 · 95% clinician | no trial data cached |
| Neuralgia | 75 | 485.4 417.5–564.4ROR 1,101.2 · χ² 35,702 / p <1e-300 | 430.5 EB05 354.8 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 413.6 · 95% clinician | no trial data cached |
| Intentional product misuse | 74 | 133.4 114.5–155.4ROR 296.8 · χ² 9,626 / p <1e-300 | 128.9 EB05 106.1 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious PRR 174.3 · 95% clinician | no trial data cached |
| Sleep disorder | 73 | 163.4 140.0–190.8ROR 357.8 · χ² 11,649 / p <1e-300 | 156.6 EB05 128.7 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 155.0 · 95% 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 Subnitrate?
In FDA FAERS, the most frequently co-reported reaction terms for Bismuth Subnitrate are multiple organ dysfunction syndrome, stress, sepsis, hyponatraemia, diabetes mellitus, drug hypersensitivity. 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 Subnitrate have an FDA boxed warning?
No. The FDA label retrieved for Bismuth Subnitrate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Bismuth Subnitrate 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 39e8a434-071f-b2b0-e063-6294a90acd00, effective 20250714; matched on
openfda.generic_name.exact:"BISMUTH SUBNITRATE") - 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, 48 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.