Fluoride side effects: what 575 FDA adverse event reports show

Potassium Nitrate And Sodium Fluoride · 19 reaction terms · 341 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

575 reports · 27% serious · 3 with death outcome · 68% 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 18 strongest signals

Reporting / coding artifact 4No 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.
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: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Oral discomfort	79	206.0 167.7–253.1ROR 238.3 · χ² 15,833 / p <1e-300	195.2 EB05 161.7 · IC025 +6.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=25 · 94% consumer	no trial data cached
Toothache	40	80.0 59.3–107.9ROR 85.8 · χ² 3,037 / p <1e-300	77.0 EB05 59.0 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 104.9 · 100% consumer	no trial data cached
Oral pain	39	62.8 46.3–85.0ROR 67.2 · χ² 2,307 / p <1e-300	60.9 EB05 46.5 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 132.7 · 92% consumer	no trial data cached
Product complaint	36	52.1 38.0–71.6ROR 55.5 · χ² 1,754 / p <1e-300	50.7 EB05 38.3 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious n=12 · 100% consumer	no trial data cached
Gingival bleeding	16	42.3 26.1–68.6ROR 43.4 · χ² 604 / p 1e-133	40.4 EB05 26.3 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.9	no trial data cached
Poor quality product administered	8	28.3 14.2–56.3ROR 28.6 · χ² 184 / p 3e-42	26.3 EB05 13.8 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Drug effect less than expected	10	25.6 13.9–47.4ROR 26.0 · χ² 213 / p 2e-48	24.3 EB05 13.8 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug effective for unapproved indication	20	24.7 16.1–38.0ROR 25.6 · χ² 432 / p 3e-96	24.2 EB05 16.5 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Dermatitis contact	7	22.3 10.7–46.5ROR 22.5 · χ² 122 / p 1e-28	20.0 EB05 8.7 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Dental caries	6	19.6 8.8–43.5ROR 19.8 · χ² 88 / p 3e-21	16.4 EB05 6.0 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 43.3	no trial data cached
Choking	10	18.6 10.1–34.4ROR 18.9 · χ² 149 / p 1e-34	17.3 EB05 9.0 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 46.9	no trial data cached
Salivary hypersecretion	5	18.1 7.5–43.3ROR 18.2 · χ² 64 / p 5e-16	13.7 EB05 4.4 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 31.5	no trial data cached
Paraesthesia oral	7	17.6 8.4–36.7ROR 17.8 · χ² 94 / p 2e-22	15.0 EB05 6.1 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.8	no trial data cached
Expired product administered	16	17.4 10.7–28.2ROR 17.9 · χ² 232 / p 1e-52	16.8 EB05 10.5 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
Glossodynia (burning tongue/mouth pain)	9	14.5 7.6–27.8ROR 14.7 · χ² 100 / p 6e-24	12.5 EB05 5.9 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.0	no trial data cached
Lip swelling	12	13.0 7.4–22.8ROR 13.3 · χ² 122 / p 1e-28	11.5 EB05 6.2 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.0	no trial data cached
Tooth disorder	8	12.9 6.5–25.7ROR 13.1 · χ² 77 / p 1e-18	10.3 EB05 4.7 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.0	no trial data cached
Accidental exposure to product	10	3.6 2.0–6.7ROR 3.7 · χ² 16 / p 2e-5	3.2 EB05 1.9 · IC025 +0.6	Reporting / coding artifact	serious PRR 43.7	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
Oral discomfort	79	206.0 167.7–253.1ROR 238.3 · χ² 15,833 / p <1e-300	195.2 EB05 161.7 · IC025 +6.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=25 · 94% consumer	no trial data cached
Toothache	40	80.0 59.3–107.9ROR 85.8 · χ² 3,037 / p <1e-300	77.0 EB05 59.0 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 104.9 · 100% consumer	no trial data cached
Oral pain	39	62.8 46.3–85.0ROR 67.2 · χ² 2,307 / p <1e-300	60.9 EB05 46.5 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 132.7 · 92% consumer	no trial data cached
Product complaint	36	52.1 38.0–71.6ROR 55.5 · χ² 1,754 / p <1e-300	50.7 EB05 38.3 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious n=12 · 100% consumer	no trial data cached
Drug effective for unapproved indication	20	24.7 16.1–38.0ROR 25.6 · χ² 432 / p 3e-96	24.2 EB05 16.5 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Expired product administered	16	17.4 10.7–28.2ROR 17.9 · χ² 232 / p 1e-52	16.8 EB05 10.5 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
Gingival bleeding	16	42.3 26.1–68.6ROR 43.4 · χ² 604 / p 1e-133	40.4 EB05 26.3 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.9	no trial data cached
Lip swelling	12	13.0 7.4–22.8ROR 13.3 · χ² 122 / p 1e-28	11.5 EB05 6.2 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.0	no trial data cached
Accidental exposure to product	10	3.6 2.0–6.7ROR 3.7 · χ² 16 / p 2e-5	3.2 EB05 1.9 · IC025 +0.6	Reporting / coding artifact	serious PRR 43.7	no trial data cached
Choking	10	18.6 10.1–34.4ROR 18.9 · χ² 149 / p 1e-34	17.3 EB05 9.0 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 46.9	no trial data cached
Drug effect less than expected	10	25.6 13.9–47.4ROR 26.0 · χ² 213 / p 2e-48	24.3 EB05 13.8 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Glossodynia (burning tongue/mouth pain)	9	14.5 7.6–27.8ROR 14.7 · χ² 100 / p 6e-24	12.5 EB05 5.9 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.0	no trial data cached
Tooth disorder	8	12.9 6.5–25.7ROR 13.1 · χ² 77 / p 1e-18	10.3 EB05 4.7 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.0	no trial data cached
Poor quality product administered	8	28.3 14.2–56.3ROR 28.6 · χ² 184 / p 3e-42	26.3 EB05 13.8 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Paraesthesia oral	7	17.6 8.4–36.7ROR 17.8 · χ² 94 / p 2e-22	15.0 EB05 6.1 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.8	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 oral discomfort, toothache, oral pain, drug effective for unapproved indication, gingival bleeding, lip swelling. 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, field patient.drug.openfda.generic_name.exact, 19 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.