Drug · FAERS side-effect profile with label screen
Sodium Fluoride side effects: what 3,660 FDA adverse event reports show
Drug class
Not stated in label
Who reports
3,660 reports · 65% serious · 504 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Directions Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbruch. brush teeth thorughly for at least one minute for at least twice a day (morning and evening), and not more than 3 times a day, or as directed by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
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 1Lab value / disease marker 2No label text to screen 37
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. 283 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 |
|---|---|---|---|---|---|---|
| Wound infection | 145 | 76.9 65.5–90.3ROR 80.0 · χ² 10,645 / p <1e-300 | 75.1 EB05 65.4 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 72.6 · ♀ 98% (drug 64%) · 93% clinician | no trial data cached |
| Helicobacter infection | 112 | 63.2 52.6–75.9ROR 65.1 · χ² 6,718 / p <1e-300 | 61.8 EB05 52.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.9 · ♀ 100% (drug 64%) · 95% clinician | no trial data cached |
| Hypercholesterolaemia | 97 | 58.2 47.8–70.9ROR 59.8 · χ² 5,347 / p <1e-300 | 57.0 EB05 48.1 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 54.6 · ♀ 95% (drug 64%) · 92% clinician | no trial data cached |
| Pemphigus | 119 | 55.0 46.0–65.6ROR 56.8 · χ² 6,193 / p <1e-300 | 54.0 EB05 46.3 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.7 · ♀ 100% (drug 64%) · 95% clinician | no trial data cached |
| Joint dislocation | 98 | 53.4 43.9–65.0ROR 54.9 · χ² 4,944 / p <1e-300 | 52.4 EB05 44.3 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.1 · ♀ 98% (drug 64%) · 96% clinician | no trial data cached |
| Folliculitis | 96 | 53.3 43.7–65.0ROR 54.7 · χ² 4,835 / p <1e-300 | 52.3 EB05 44.1 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.4 · ♀ 100% (drug 64%) · 95% clinician | no trial data cached |
| Autoimmune disorder | 87 | 52.2 42.3–64.3ROR 53.4 · χ² 4,277 / p <1e-300 | 51.1 EB05 42.7 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.3 · ♀ 97% (drug 64%) | no trial data cached |
| Foot deformity | 91 | 47.0 38.3–57.6ROR 48.2 · χ² 4,020 / p <1e-300 | 46.2 EB05 38.8 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.2 · ♀ 100% (drug 64%) · 92% clinician | no trial data cached |
| Laryngitis | 89 | 47.0 38.2–57.8ROR 48.1 · χ² 3,930 / p <1e-300 | 46.2 EB05 38.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=87 · ♀ 100% (drug 64%) · 94% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 83 | 42.9 34.6–53.1ROR 43.8 · χ² 3,329 / p <1e-300 | 42.2 EB05 35.1 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious PRR 43.1 · ♀ 97% (drug 64%) · 96% clinician | no trial data cached |
| Pericarditis | 121 | 41.6 34.9–49.6ROR 43.0 · χ² 4,721 / p <1e-300 | 41.0 EB05 35.3 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.1 · ♀ 100% (drug 64%) · 95% clinician | no trial data cached |
| Joint range of motion decreased | 97 | 41.6 34.1–50.6ROR 42.7 · χ² 3,774 / p <1e-300 | 41.0 EB05 34.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.9 · ♀ 100% (drug 64%) · 98% clinician | no trial data cached |
| Prescribed underdose | 137 | 39.3 33.3–46.4ROR 40.8 · χ² 5,048 / p <1e-300 | 38.9 EB05 33.7 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 59.1 · ♀ 100% (drug 64%) · 96% clinician | no trial data cached |
| Hand deformity | 88 | 38.5 31.3–47.4ROR 39.4 · χ² 3,157 / p <1e-300 | 38.0 EB05 31.8 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.1 · ♀ 100% (drug 64%) · 98% clinician | no trial data cached |
| Sciatica | 103 | 37.2 30.7–45.0ROR 38.2 · χ² 3,568 / p <1e-300 | 36.7 EB05 31.1 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.8 · ♀ 97% (drug 64%) · 91% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 129 | 33.0 27.8–39.1ROR 34.2 · χ² 3,952 / p <1e-300 | 32.7 EB05 28.2 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.4 · ♀ 91% (drug 64%) | no trial data cached |
| Oral discomfort | 80 | 32.9 26.5–40.9ROR 33.6 · χ² 2,428 / p <1e-300 | 32.5 EB05 26.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · 87% consumer | no trial data cached |
| Prescribed overdose | 98 | 28.9 23.8–35.2ROR 29.7 · χ² 2,605 / p <1e-300 | 28.7 EB05 24.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.4 · ♀ 96% (drug 64%) · 93% clinician | no trial data cached |
| Fibromyalgia | 122 | 28.7 24.1–34.2ROR 29.7 · χ² 3,222 / p <1e-300 | 28.5 EB05 24.5 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.2 · ♀ 100% (drug 64%) · 93% clinician | no trial data cached |
| Irritable bowel syndrome | 107 | 28.6 23.7–34.5ROR 29.4 · χ² 2,813 / p <1e-300 | 28.4 EB05 24.1 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.2 · ♀ 100% (drug 64%) · 93% clinician | no trial data cached |
| Hip arthroplasty | 76 | 28.6 22.9–35.7ROR 29.2 · χ² 1,988 / p <1e-300 | 28.3 EB05 23.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.2 · ♀ 100% (drug 64%) · 96% clinician | no trial data cached |
| Wound | 139 | 28.6 24.3–33.6ROR 29.7 · χ² 3,657 / p <1e-300 | 28.3 EB05 24.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.0 · ♀ 100% (drug 64%) · 96% clinician | no trial data cached |
| Pulmonary fibrosis | 95 | 28.4 23.3–34.7ROR 29.1 · χ² 2,474 / p <1e-300 | 28.1 EB05 23.7 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.5 · ♀ 95% (drug 64%) · 91% clinician | no trial data cached |
| Lower limb fracture | 94 | 28.1 23.0–34.4ROR 28.8 · χ² 2,422 / p <1e-300 | 27.9 EB05 23.4 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.8 · ♀ 100% (drug 64%) · 90% clinician | no trial data cached |
| Synovitis | 87 | 27.5 22.4–33.9ROR 28.2 · χ² 2,190 / p <1e-300 | 27.3 EB05 22.8 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.6 · ♀ 100% (drug 64%) · 97% clinician | no trial data cached |
| Hepatic cirrhosis | 87 | 26.6 21.6–32.7ROR 27.2 · χ² 2,109 / p <1e-300 | 26.3 EB05 22.0 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.9 · ♀ 100% (drug 64%) · 94% clinician | no trial data cached |
| Type 2 diabetes mellitus | 156 | 26.4 22.6–30.8ROR 27.5 · χ² 3,773 / p <1e-300 | 26.2 EB05 22.9 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.7 · ♀ 97% (drug 64%) · 94% clinician | no trial data cached |
| Liver injury | 101 | 23.8 19.7–28.9ROR 24.5 · χ² 2,181 / p <1e-300 | 23.7 EB05 20.0 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.0 · ♀ 96% (drug 64%) · 92% clinician | no trial data cached |
| Liver function test increased | 88 | 23.6 19.2–29.0ROR 24.1 · χ² 1,872 / p <1e-300 | 23.4 EB05 19.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.7 · ♀ 100% (drug 64%) · 98% clinician | no trial data cached |
| Joint stiffness | 102 | 22.2 18.3–26.9ROR 22.8 · χ² 2,037 / p <1e-300 | 22.0 EB05 18.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.2 · ♀ 100% (drug 64%) · 95% clinician | no trial data cached |
| Disability | 74 | 21.3 17.0–26.8ROR 21.8 · χ² 1,411 / p <1e-300 | 21.2 EB05 17.4 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.5 · ♀ 94% (drug 64%) · 90% clinician | no trial data cached |
| Osteoarthritis | 148 | 19.9 17.0–23.3ROR 20.7 · χ² 2,631 / p <1e-300 | 19.8 EB05 17.2 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.7 · ♀ 96% (drug 64%) | no trial data cached |
| Ear infection | 90 | 19.3 15.8–23.7ROR 19.8 · χ² 1,544 / p <1e-300 | 19.2 EB05 16.1 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.7 · ♀ 97% (drug 64%) | no trial data cached |
| C-reactive protein increased | 122 | 19.1 16.1–22.8ROR 19.8 · χ² 2,076 / p <1e-300 | 19.0 EB05 16.4 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 17.6 · 96% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 149 | 18.4 15.7–21.6ROR 19.2 · χ² 2,434 / p <1e-300 | 18.3 EB05 16.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.1 · ♀ 93% (drug 64%) | no trial data cached |
| Impaired healing | 104 | 18.1 14.9–21.8ROR 18.6 · χ² 1,657 / p <1e-300 | 18.0 EB05 15.2 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 19.1 · ♀ 97% (drug 64%) · 91% clinician | no trial data cached |
| Knee arthroplasty | 66 | 18.1 14.2–22.9ROR 18.4 · χ² 1,044 / p 2e-229 | 17.9 EB05 14.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.7 · ♀ 100% (drug 64%) · 100% clinician | no trial data cached |
| Osteoporosis | 128 | 17.7 14.9–21.0ROR 18.3 · χ² 2,001 / p <1e-300 | 17.6 EB05 15.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.2 · ♀ 93% (drug 64%) · 91% clinician | no trial data cached |
| Dental caries | 34 | 17.6 12.6–24.5ROR 17.7 · χ² 513 / p 7e-114 | 17.3 EB05 12.9 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.3 · 81% consumer | no trial data cached |
| Gait inability | 101 | 17.4 14.4–21.1ROR 17.9 · χ² 1,543 / p <1e-300 | 17.3 EB05 14.6 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.3 · ♀ 96% (drug 64%) · 91% 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 |
|---|---|---|---|---|---|---|
| Pain | 286 | 2.6 2.4–3.0ROR 2.8 · χ² 299 / p 2e-67 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial data cached |
| Pneumonia (lung infection) | 238 | 4.2 3.7–4.7ROR 4.4 · χ² 583 / p 3e-129 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Pyrexia (fever) | 236 | 3.9 3.4–4.4ROR 4.1 · χ² 509 / p 4e-113 | 3.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Dizziness | 233 | 2.7 2.4–3.0ROR 2.8 · χ² 246 / p 1e-55 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | no trial data cached |
| Weight decreased (weight loss) | 226 | 4.6 4.1–5.2ROR 4.8 · χ² 643 / p 3e-142 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Rash | 218 | 2.9 2.5–3.3ROR 3.0 · χ² 267 / p 2e-60 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Nasopharyngitis (common cold) | 204 | 6.3 5.5–7.2ROR 6.6 · χ² 909 / p 7e-200 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.5 · ♀ 90% (drug 64%) | no trial data cached |
| Arthralgia (joint pain) | 203 | 2.8 2.4–3.2ROR 2.9 · χ² 235 / p 2e-53 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 · ♀ 86% (drug 64%) | no trial data cached |
| Weight increased (weight gain) | 197 | 5.0 4.4–5.8ROR 5.3 · χ² 639 / p 3e-141 | 5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 · ♀ 92% (drug 64%) | no trial data cached |
| Pain in extremity | 188 | 3.6 3.2–4.2ROR 3.8 · χ² 359 / p 2e-80 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 · ♀ 90% (drug 64%) | no trial data cached |
| Anxiety | 188 | 3.7 3.3–4.3ROR 3.9 · χ² 381 / p 3e-85 | 3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | no trial data cached |
| Peripheral swelling | 187 | 6.9 6.0–8.0ROR 7.3 · χ² 950 / p 6e-209 | 6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 · ♀ 90% (drug 64%) | no trial data cached |
| Pruritus (itching) | 183 | 2.8 2.4–3.2ROR 2.8 · χ² 206 / p 4e-47 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 · ♀ 85% (drug 64%) | no trial data cached |
| Condition aggravated | 176 | 3.3 2.9–3.8ROR 3.4 · χ² 286 / p 2e-64 | 3.3 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Urticaria (hives) | 175 | 6.0 5.2–6.9ROR 6.2 · χ² 727 / p 2e-160 | 5.9 EB05 5.2 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 · ♀ 91% (drug 64%) | 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 Fluoride?
In FDA FAERS, the most frequently co-reported reaction terms for Fluoride are pain, pneumonia, pyrexia, dizziness, weight decreased, rash. 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 Fluoride have an FDA boxed warning?
No. The FDA label retrieved for Fluoride has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fluoride 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 18295a1c-c2a6-489b-be34-9252b9e1e2b8, effective 20251121; matched on
openfda.generic_name.exact:"FLUORIDE") - 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, 323 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.