Drug · FAERS side-effect profile with label screen
Chlorate side effects: what 402 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Potassium Chlorate (Kali Chloricum)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
402 reports · 65% serious · 135 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
See symptoms on front panel. Relieves pain from canker sores
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 32 strongest signals
Reporting / coding artifact 4Lab value / disease marker 2No label text to screen 26
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. 7 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 | 88 | 498.5 414.0–600.3ROR 638.0 · χ² 42,803 / p <1e-300 | 445.7 EB05 372.9 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 444.0 · ♀ 19% (drug 55%) · 97% clinician | no trial data cached |
| Ventricular fibrillation | 77 | 363.1 296.8–444.3ROR 448.9 · χ² 27,268 / p <1e-300 | 330.9 EB05 273.4 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 320.3 · ♀ 7% (drug 55%) · 96% clinician | no trial data cached |
| Cardiogenic shock | 85 | 312.6 258.6–377.8ROR 396.1 · χ² 25,948 / p <1e-300 | 290.4 EB05 242.2 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 275.2 · ♀ 19% (drug 55%) · 96% clinician | no trial data cached |
| Hyperlipidaemia | 39 | 170.3 126.3–229.6ROR 188.5 · χ² 6,377 / p <1e-300 | 156.8 EB05 119.7 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 165.7 · 97% clinician | no trial data cached |
| Ascites | 88 | 156.5 130.1–188.3ROR 200.1 · χ² 13,420 / p <1e-300 | 151.0 EB05 126.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 140.3 · ♀ 19% (drug 55%) · 97% clinician | no trial data cached |
| Bacterial infection | 53 | 149.3 116.1–191.9ROR 171.8 · χ² 7,643 / p <1e-300 | 141.4 EB05 112.2 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 149.6 · ♀ 34% (drug 55%) · 96% clinician | no trial data cached |
| Incorrect route of product administration | 46 | 143.2 109.0–188.0ROR 161.5 · χ² 6,340 / p <1e-300 | 134.9 EB05 105.2 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 252.9 · ♀ 14% (drug 55%) · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 75 | 140.6 114.6–172.5ROR 172.6 · χ² 10,240 / p <1e-300 | 135.4 EB05 111.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 124.2 · ♀ 7% (drug 55%) · 96% clinician | no trial data cached |
| Blood test abnormal | 37 | 137.8 101.3–187.4ROR 151.7 · χ² 4,880 / p <1e-300 | 128.5 EB05 97.3 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 186.6 · 97% clinician | no trial data cached |
| Gout | 42 | 122.2 91.8–162.8ROR 136.4 · χ² 4,922 / p <1e-300 | 115.6 EB05 89.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 159.5 · 98% clinician | no trial data cached |
| End stage renal disease | 39 | 110.7 82.1–149.2ROR 122.5 · χ² 4,124 / p <1e-300 | 104.9 EB05 80.1 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 97.8 · 97% clinician | no trial data cached |
| Ulcer | 33 | 108.3 78.0–150.2ROR 117.8 · χ² 3,396 / p <1e-300 | 101.8 EB05 75.9 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.2 · ♀ 24% (drug 55%) · 97% clinician | no trial data cached |
| Neuralgia | 48 | 103.4 79.3–134.9ROR 117.3 · χ² 4,763 / p <1e-300 | 99.3 EB05 77.8 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 135.9 · ♀ 14% (drug 55%) · 96% clinician | no trial data cached |
| Blood cholesterol increased | 62 | 69.4 55.2–87.3ROR 81.9 · χ² 4,117 / p <1e-300 | 67.9 EB05 54.9 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious PRR 93.3 · ♀ 29% (drug 55%) · 98% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 73 | 67.8 55.1–83.5ROR 82.7 · χ² 4,747 / p <1e-300 | 66.6 EB05 54.7 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.6 · ♀ 8% (drug 55%) · 96% clinician | no trial data cached |
| Dry mouth | 86 | 55.4 46.0–66.9ROR 70.3 · χ² 4,556 / p <1e-300 | 54.8 EB05 45.7 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 96.3 · ♀ 19% (drug 55%) · 95% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 53 | 53.1 41.3–68.2ROR 61.0 · χ² 2,660 / p <1e-300 | 52.1 EB05 41.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 54.9 · ♀ 33% (drug 55%) · 98% clinician | no trial data cached |
| Aspiration | 11 | 53.0 29.6–95.0ROR 54.5 · χ² 510 / p 3e-113 | 48.8 EB05 29.1 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.2 | no trial data cached |
| Stress | 73 | 53.0 43.1–65.2ROR 64.5 · χ² 3,681 / p <1e-300 | 52.3 EB05 42.9 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 77.9 · ♀ 9% (drug 55%) · 96% clinician | no trial data cached |
| Liver function test increased | 19 | 46.5 30.0–72.1ROR 48.8 · χ² 801 / p 1e-176 | 44.5 EB05 30.1 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 64.3 | no trial data cached |
| Abdominal distension (bloating) | 92 | 46.2 38.6–55.3ROR 59.6 · χ² 4,039 / p <1e-300 | 45.7 EB05 38.4 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.8 · ♀ 20% (drug 55%) · 95% clinician | no trial data cached |
| General physical health deterioration | 90 | 40.9 34.1–49.1ROR 52.4 · χ² 3,479 / p <1e-300 | 40.5 EB05 34.0 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 41.4 · ♀ 22% (drug 55%) · 96% clinician | no trial data cached |
| Diabetes mellitus | 59 | 40.2 31.8–50.9ROR 47.0 · χ² 2,224 / p <1e-300 | 39.7 EB05 31.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.7 · ♀ 30% (drug 55%) · 97% clinician | no trial data cached |
| Sepsis (blood infection) | 78 | 36.5 29.9–44.5ROR 45.0 · χ² 2,669 / p <1e-300 | 36.2 EB05 29.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.5 · ♀ 10% (drug 55%) · 95% clinician | no trial data cached |
| Pulmonary mass | 10 | 35.1 19.0–64.7ROR 36.0 · χ² 298 / p 4e-67 | 33.0 EB05 19.1 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.9 | no trial data cached |
| Sleep disorder | 44 | 32.8 24.8–43.4ROR 36.7 · χ² 1,329 / p 2e-291 | 32.4 EB05 25.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.0 · ♀ 18% (drug 55%) · 95% clinician | no trial data cached |
| Thrombosis | 49 | 31.7 24.4–41.2ROR 36.0 · χ² 1,431 / p <1e-300 | 31.3 EB05 24.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.1 · ♀ 14% (drug 55%) · 98% clinician | no trial data cached |
| Blood creatinine increased | 39 | 31.1 23.1–41.9ROR 34.3 · χ² 1,110 / p 1e-243 | 30.7 EB05 23.4 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 30.9 · 95% clinician | no trial data cached |
| Lower respiratory tract infection | 27 | 31.1 21.6–44.8ROR 33.3 · χ² 758 / p 4e-167 | 30.5 EB05 22.0 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.2 · ♀ 22% (drug 55%) · 96% clinician | no trial data cached |
| Swelling | 51 | 28.5 22.1–36.8ROR 32.5 · χ² 1,331 / p 9e-292 | 28.2 EB05 22.3 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.2 · ♀ 16% (drug 55%) · 96% clinician | no trial data cached |
| Intentional product misuse | 47 | 28.2 21.6–36.9ROR 31.8 · χ² 1,212 / p 7e-266 | 27.9 EB05 21.9 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 55.6 · ♀ 15% (drug 55%) · 96% clinician | no trial data cached |
| Transaminases increased | 11 | 25.8 14.4–46.3ROR 26.5 · χ² 239 / p 4e-54 | 24.7 EB05 14.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.4 | 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 |
|---|---|---|---|---|---|---|
| Abdominal distension (bloating) | 92 | 46.2 38.6–55.3ROR 59.6 · χ² 4,039 / p <1e-300 | 45.7 EB05 38.4 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.8 · ♀ 20% (drug 55%) · 95% clinician | no trial data cached |
| General physical health deterioration | 90 | 40.9 34.1–49.1ROR 52.4 · χ² 3,479 / p <1e-300 | 40.5 EB05 34.0 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 41.4 · ♀ 22% (drug 55%) · 96% clinician | no trial data cached |
| Ascites | 88 | 156.5 130.1–188.3ROR 200.1 · χ² 13,420 / p <1e-300 | 151.0 EB05 126.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 140.3 · ♀ 19% (drug 55%) · 97% clinician | no trial data cached |
| Appendicitis | 88 | 498.5 414.0–600.3ROR 638.0 · χ² 42,803 / p <1e-300 | 445.7 EB05 372.9 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 444.0 · ♀ 19% (drug 55%) · 97% clinician | no trial data cached |
| Dry mouth | 86 | 55.4 46.0–66.9ROR 70.3 · χ² 4,556 / p <1e-300 | 54.8 EB05 45.7 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 96.3 · ♀ 19% (drug 55%) · 95% clinician | no trial data cached |
| Cardiogenic shock | 85 | 312.6 258.6–377.8ROR 396.1 · χ² 25,948 / p <1e-300 | 290.4 EB05 242.2 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 275.2 · ♀ 19% (drug 55%) · 96% clinician | no trial data cached |
| Sepsis (blood infection) | 78 | 36.5 29.9–44.5ROR 45.0 · χ² 2,669 / p <1e-300 | 36.2 EB05 29.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.5 · ♀ 10% (drug 55%) · 95% clinician | no trial data cached |
| Ventricular fibrillation | 77 | 363.1 296.8–444.3ROR 448.9 · χ² 27,268 / p <1e-300 | 330.9 EB05 273.4 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 320.3 · ♀ 7% (drug 55%) · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 75 | 140.6 114.6–172.5ROR 172.6 · χ² 10,240 / p <1e-300 | 135.4 EB05 111.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 124.2 · ♀ 7% (drug 55%) · 96% clinician | no trial data cached |
| Stress | 73 | 53.0 43.1–65.2ROR 64.5 · χ² 3,681 / p <1e-300 | 52.3 EB05 42.9 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 77.9 · ♀ 9% (drug 55%) · 96% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 73 | 67.8 55.1–83.5ROR 82.7 · χ² 4,747 / p <1e-300 | 66.6 EB05 54.7 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.6 · ♀ 8% (drug 55%) · 96% clinician | no trial data cached |
| Blood cholesterol increased | 62 | 69.4 55.2–87.3ROR 81.9 · χ² 4,117 / p <1e-300 | 67.9 EB05 54.9 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious PRR 93.3 · ♀ 29% (drug 55%) · 98% clinician | no trial data cached |
| Diabetes mellitus | 59 | 40.2 31.8–50.9ROR 47.0 · χ² 2,224 / p <1e-300 | 39.7 EB05 31.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.7 · ♀ 30% (drug 55%) · 97% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 53 | 53.1 41.3–68.2ROR 61.0 · χ² 2,660 / p <1e-300 | 52.1 EB05 41.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 54.9 · ♀ 33% (drug 55%) · 98% clinician | no trial data cached |
| Bacterial infection | 53 | 149.3 116.1–191.9ROR 171.8 · χ² 7,643 / p <1e-300 | 141.4 EB05 112.2 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 149.6 · ♀ 34% (drug 55%) · 96% 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 Chlorate?
In FDA FAERS, the most frequently co-reported reaction terms for Chlorate are abdominal distension, ascites, appendicitis, dry mouth, cardiogenic shock, sepsis. 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 Chlorate have an FDA boxed warning?
No. The FDA label retrieved for Chlorate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Chlorate 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 3a880519-b14f-1eaf-e063-6294a90aaceb, effective 20250722; matched on
openfda.generic_name.exact:"POTASSIUM CHLORATE") - 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, 39 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.