Drug · FAERS side-effect profile with label screen
Potassium Bromide side effects: what 359 FDA adverse event reports show
Drug class
Not stated in label
Who reports
359 reports · 85% serious · 43 with death outcome · 49% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Use the leaflet enclosed for detail.
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 4Lab value / disease marker 1No label text to screen 14
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. 1 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 |
|---|---|---|---|---|---|---|
| Status epilepticus | 33 | 170.8 123.3–236.6ROR 188.0 · χ² 5,390 / p <1e-300 | 155.2 EB05 115.6 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 115.6 · ♀ 14% (drug 49%) · 97% clinician | no trial data cached |
| Ataxia | 17 | 83.4 52.4–132.7ROR 87.5 · χ² 1,302 / p 2e-285 | 76.4 EB05 50.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.1 | no trial data cached |
| Prescribed underdose | 23 | 67.4 45.4–100.1ROR 72.0 · χ² 1,439 / p <1e-300 | 63.9 EB05 44.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.3 · 100% clinician | no trial data cached |
| Aspiration | 9 | 48.6 25.5–92.6ROR 49.8 · χ² 373 / p 2e-83 | 44.3 EB05 24.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.8 | no trial data cached |
| Full blood count abnormal | 8 | 44.3 22.3–88.0ROR 45.3 · χ² 297 / p 8e-67 | 40.3 EB05 21.9 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 39.9 | no trial data cached |
| Epilepsy | 23 | 44.1 29.7–65.4ROR 47.0 · χ² 926 / p 1e-203 | 42.6 EB05 29.9 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.0 · 100% clinician | no trial data cached |
| Appendicitis | 7 | 44.0 21.1–91.7ROR 44.9 · χ² 253 / p 3e-57 | 39.5 EB05 20.4 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.2 | no trial data cached |
| Hypercholesterolaemia | 7 | 42.8 20.5–89.1ROR 43.6 · χ² 245 / p 1e-55 | 38.5 EB05 19.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.8 | no trial data cached |
| Ventricular fibrillation | 8 | 42.0 21.2–83.3ROR 42.9 · χ² 280 / p 3e-63 | 38.4 EB05 20.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.5 | no trial data cached |
| Micturition urgency | 8 | 41.2 20.8–81.8ROR 42.2 · χ² 275 / p 4e-62 | 37.8 EB05 20.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.2 | no trial data cached |
| Drug level decreased | 7 | 40.0 19.2–83.3ROR 40.8 · χ² 229 / p 6e-52 | 36.2 EB05 18.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 33.5 | no trial data cached |
| Incorrect route of product administration | 11 | 38.3 21.4–68.5ROR 39.4 · χ² 363 / p 4e-81 | 36.0 EB05 21.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 51.8 | no trial data cached |
| Encephalopathy | 16 | 38.2 23.6–61.6ROR 39.9 · χ² 543 / p 2e-120 | 36.6 EB05 23.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.0 | no trial data cached |
| Cardiogenic shock | 8 | 32.8 16.5–65.0ROR 33.5 · χ² 216 / p 4e-49 | 30.4 EB05 16.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.2 | no trial data cached |
| Altered state of consciousness | 11 | 29.8 16.7–53.4ROR 30.7 · χ² 278 / p 8e-63 | 28.4 EB05 16.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.4 | no trial data cached |
| Blood test abnormal | 7 | 29.1 14.0–60.7ROR 29.7 · χ² 163 / p 1e-37 | 26.7 EB05 13.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 30.2 | no trial data cached |
| Generalised tonic-clonic seizure | 7 | 25.0 12.0–52.1ROR 25.5 · χ² 138 / p 3e-32 | 22.8 EB05 10.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.2 | no trial data cached |
| Drug level increased | 6 | 21.2 9.6–46.8ROR 21.5 · χ² 96 / p 6e-23 | 18.1 EB05 6.7 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 13.2 | no trial data cached |
| Cardiovascular disorder | 8 | 18.3 9.2–36.3ROR 18.7 · χ² 114 / p 6e-27 | 16.3 EB05 7.3 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.3 | 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 |
|---|---|---|---|---|---|---|
| Status epilepticus | 33 | 170.8 123.3–236.6ROR 188.0 · χ² 5,390 / p <1e-300 | 155.2 EB05 115.6 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 115.6 · ♀ 14% (drug 49%) · 97% clinician | no trial data cached |
| Epilepsy | 23 | 44.1 29.7–65.4ROR 47.0 · χ² 926 / p 1e-203 | 42.6 EB05 29.9 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.0 · 100% clinician | no trial data cached |
| Prescribed underdose | 23 | 67.4 45.4–100.1ROR 72.0 · χ² 1,439 / p <1e-300 | 63.9 EB05 44.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.3 · 100% clinician | no trial data cached |
| Ataxia | 17 | 83.4 52.4–132.7ROR 87.5 · χ² 1,302 / p 2e-285 | 76.4 EB05 50.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.1 | no trial data cached |
| Encephalopathy | 16 | 38.2 23.6–61.6ROR 39.9 · χ² 543 / p 2e-120 | 36.6 EB05 23.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.0 | no trial data cached |
| Altered state of consciousness | 11 | 29.8 16.7–53.4ROR 30.7 · χ² 278 / p 8e-63 | 28.4 EB05 16.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.4 | no trial data cached |
| Incorrect route of product administration | 11 | 38.3 21.4–68.5ROR 39.4 · χ² 363 / p 4e-81 | 36.0 EB05 21.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 51.8 | no trial data cached |
| Aspiration | 9 | 48.6 25.5–92.6ROR 49.8 · χ² 373 / p 2e-83 | 44.3 EB05 24.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.8 | no trial data cached |
| Cardiovascular disorder | 8 | 18.3 9.2–36.3ROR 18.7 · χ² 114 / p 6e-27 | 16.3 EB05 7.3 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.3 | no trial data cached |
| Cardiogenic shock | 8 | 32.8 16.5–65.0ROR 33.5 · χ² 216 / p 4e-49 | 30.4 EB05 16.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.2 | no trial data cached |
| Micturition urgency | 8 | 41.2 20.8–81.8ROR 42.2 · χ² 275 / p 4e-62 | 37.8 EB05 20.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.2 | no trial data cached |
| Ventricular fibrillation | 8 | 42.0 21.2–83.3ROR 42.9 · χ² 280 / p 3e-63 | 38.4 EB05 20.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.5 | no trial data cached |
| Full blood count abnormal | 8 | 44.3 22.3–88.0ROR 45.3 · χ² 297 / p 8e-67 | 40.3 EB05 21.9 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 39.9 | no trial data cached |
| Generalised tonic-clonic seizure | 7 | 25.0 12.0–52.1ROR 25.5 · χ² 138 / p 3e-32 | 22.8 EB05 10.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.2 | no trial data cached |
| Blood test abnormal | 7 | 29.1 14.0–60.7ROR 29.7 · χ² 163 / p 1e-37 | 26.7 EB05 13.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 30.2 | 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 Potassium Bromide?
In FDA FAERS, the most frequently co-reported reaction terms for Potassium Bromide are status epilepticus, epilepsy, prescribed underdose, ataxia, encephalopathy, altered state of consciousness. 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 Potassium Bromide have an FDA boxed warning?
No. The FDA label retrieved for Potassium Bromide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Potassium Bromide 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 2fac6a11-269a-5792-e063-6294a90a12f9, effective 20250526; matched on
openfda.generic_name.exact:"POTASSIUM BROMIDE") - 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, 20 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.