Stannous Fluoride side effects: what 717 FDA adverse event reports show
Drug class
Not stated in label
Who reports
717 reports · 44% serious · 14 with death outcome · 68% female
Used for
Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product must be used under the supervision of a dentist.
Boxed warning
None in the current label
Causality screen of the 20 strongest signals
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. 9 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Oral discomfort | 101 | 213.5 178.0–256.0ROR 248.3 · χ² 21,007 / p <1e-300 | 203.8 EB05 172.6 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=46 · 93% consumer | no trial data cached |
| Toothache | 46 | 74.4 56.3–98.5ROR 79.5 · χ² 3,254 / p <1e-300 | 72.1 EB05 56.3 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.0 · 91% consumer | no trial data cached |
| Oral pain | 51 | 66.4 51.0–86.6ROR 71.4 · χ² 3,218 / p <1e-300 | 64.8 EB05 51.2 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 97.0 · 96% consumer | no trial data cached |
| Hypoaesthesia oral | 25 | 48.6 33.0–71.4ROR 50.3 · χ² 1,116 / p 5e-245 | 46.9 EB05 33.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.3 · 96% consumer | no trial data cached |
| Gingival bleeding | 18 | 38.5 24.4–60.8ROR 39.5 · χ² 620 / p 4e-137 | 37.1 EB05 24.8 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.3 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 29 | 37.9 26.5–54.2ROR 39.5 · χ² 1,006 / p 5e-221 | 37.0 EB05 27.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.2 · 100% consumer | no trial data cached |
| Ageusia (loss of taste) | 29 | 33.9 23.7–48.4ROR 35.3 · χ² 893 / p 1e-196 | 33.2 EB05 24.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.9 · 82% consumer | no trial data cached |
| Lip swelling | 33 | 29.0 20.8–40.5ROR 30.4 · χ² 866 / p 1e-190 | 28.6 EB05 21.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.0 · 100% consumer | no trial data cached |
| Paraesthesia oral | 12 | 24.4 13.9–42.8ROR 24.8 · χ² 246 / p 8e-56 | 23.4 EB05 14.1 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.0 | no trial data cached |
| Drug effective for unapproved indication | 21 | 21.0 13.8–32.0ROR 21.6 · χ² 381 / p 5e-85 | 20.6 EB05 14.1 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Stomatitis (mouth sores) | 43 | 20.7 15.5–27.7ROR 22.0 · χ² 789 / p 7e-174 | 20.5 EB05 15.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.8 · 90% consumer | no trial data cached |
| Choking | 13 | 19.6 11.4–33.5ROR 19.9 · χ² 211 / p 5e-48 | 18.8 EB05 11.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.2 | no trial data cached |
| Product complaint | 16 | 18.7 11.5–30.4ROR 19.1 · χ² 251 / p 7e-57 | 18.1 EB05 11.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=8 | no trial data cached |
| Mouth ulceration | 12 | 16.7 9.5–29.2ROR 16.9 · χ² 162 / p 3e-37 | 15.6 EB05 8.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.1 | no trial data cached |
| Swollen tongue | 17 | 15.9 9.9–25.4ROR 16.2 · χ² 223 / p 1e-50 | 15.2 EB05 9.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.4 | no trial data cached |
| Tooth loss | 11 | 15.4 8.6–27.7ROR 15.6 · χ² 134 / p 3e-31 | 14.0 EB05 7.3 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.2 | no trial data cached |
| Tooth disorder | 10 | 13.1 7.1–24.2ROR 13.2 · χ² 100 / p 8e-24 | 11.1 EB05 5.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.8 | no trial data cached |
| Throat irritation | 18 | 11.8 7.5–18.6ROR 12.0 · χ² 167 / p 2e-38 | 10.7 EB05 6.7 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.8 | no trial data cached |
| Dysgeusia (altered taste) | 29 | 11.3 7.9–16.2ROR 11.8 · χ² 264 / p 1e-59 | 10.7 EB05 7.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.4 · 88% consumer | no trial data cached |
| Accidental exposure to product | 12 | 3.5 2.0–6.1ROR 3.6 · χ² 19 / p 6e-6 | 3.2 EB05 2.0 · IC025 +0.7 | Reporting / coding artifact | serious PRR 34.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 101 | 213.5 178.0–256.0ROR 248.3 · χ² 21,007 / p <1e-300 | 203.8 EB05 172.6 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=46 · 93% consumer | no trial data cached |
| Oral pain | 51 | 66.4 51.0–86.6ROR 71.4 · χ² 3,218 / p <1e-300 | 64.8 EB05 51.2 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 97.0 · 96% consumer | no trial data cached |
| Toothache | 46 | 74.4 56.3–98.5ROR 79.5 · χ² 3,254 / p <1e-300 | 72.1 EB05 56.3 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.0 · 91% consumer | no trial data cached |
| Stomatitis (mouth sores) | 43 | 20.7 15.5–27.7ROR 22.0 · χ² 789 / p 7e-174 | 20.5 EB05 15.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.8 · 90% consumer | no trial data cached |
| Lip swelling | 33 | 29.0 20.8–40.5ROR 30.4 · χ² 866 / p 1e-190 | 28.6 EB05 21.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.0 · 100% consumer | no trial data cached |
| Dysgeusia (altered taste) | 29 | 11.3 7.9–16.2ROR 11.8 · χ² 264 / p 1e-59 | 10.7 EB05 7.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.4 · 88% consumer | no trial data cached |
| Ageusia (loss of taste) | 29 | 33.9 23.7–48.4ROR 35.3 · χ² 893 / p 1e-196 | 33.2 EB05 24.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.9 · 82% consumer | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 29 | 37.9 26.5–54.2ROR 39.5 · χ² 1,006 / p 5e-221 | 37.0 EB05 27.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.2 · 100% consumer | no trial data cached |
| Hypoaesthesia oral | 25 | 48.6 33.0–71.4ROR 50.3 · χ² 1,116 / p 5e-245 | 46.9 EB05 33.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.3 · 96% consumer | no trial data cached |
| Drug effective for unapproved indication | 21 | 21.0 13.8–32.0ROR 21.6 · χ² 381 / p 5e-85 | 20.6 EB05 14.1 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Throat irritation | 18 | 11.8 7.5–18.6ROR 12.0 · χ² 167 / p 2e-38 | 10.7 EB05 6.7 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.8 | no trial data cached |
| Gingival bleeding | 18 | 38.5 24.4–60.8ROR 39.5 · χ² 620 / p 4e-137 | 37.1 EB05 24.8 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.3 | no trial data cached |
| Swollen tongue | 17 | 15.9 9.9–25.4ROR 16.2 · χ² 223 / p 1e-50 | 15.2 EB05 9.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.4 | no trial data cached |
| Product complaint | 16 | 18.7 11.5–30.4ROR 19.1 · χ² 251 / p 7e-57 | 18.1 EB05 11.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=8 | no trial data cached |
| Choking | 13 | 19.6 11.4–33.5ROR 19.9 · χ² 211 / p 5e-48 | 18.8 EB05 11.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | 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 Stannous Fluoride?
In FDA FAERS, the most frequently co-reported reaction terms for Stannous Fluoride are oral discomfort, oral pain, toothache, stomatitis, lip swelling, dysgeusia. 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 Stannous Fluoride have an FDA boxed warning?
No. The FDA label retrieved for Stannous Fluoride has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Stannous 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 f8721665-b304-4b1c-9bda-385d7671d099, effective 20240422; matched on
openfda.generic_name.exact:"STANNOUS FLUORIDE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 29 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.