Drug · FAERS side-effect profile with label screen
Clear Mint and Gel Toothpaste side effects: what 1,066 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Clear Mint, Gel Toothpaste (Sodium Fluoride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
1,066 reports · 82% serious · 347 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
(s) Helps protect against cavities
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. 91 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 | 139 | 254.6 217.8–297.6ROR 292.6 · χ² 34,423 / p <1e-300 | 242.9 EB05 210.9 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 190.5 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Helicobacter infection | 112 | 218.3 183.0–260.4ROR 243.8 · χ² 23,752 / p <1e-300 | 208.2 EB05 177.8 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 161.3 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Hypercholesterolaemia | 93 | 192.9 158.7–234.5ROR 211.2 · χ² 17,397 / p <1e-300 | 183.8 EB05 154.6 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 143.5 · ♀ 99% (drug 65%) · 96% clinician | no trial data cached |
| Pemphigus | 119 | 189.9 160.2–225.2ROR 213.6 · χ² 21,972 / p <1e-300 | 182.6 EB05 156.7 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 133.3 · ♀ 99% (drug 65%) · 95% clinician | no trial data cached |
| Folliculitis | 95 | 182.4 150.4–221.2ROR 200.1 · χ² 16,808 / p <1e-300 | 174.4 EB05 146.9 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 150.1 · ♀ 99% (drug 65%) · 96% clinician | no trial data cached |
| Joint dislocation | 96 | 180.8 149.3–219.0ROR 198.6 · χ² 16,839 / p <1e-300 | 173.0 EB05 145.9 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 142.6 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Autoimmune disorder | 79 | 163.5 132.1–202.4ROR 176.5 · χ² 12,500 / p <1e-300 | 156.1 EB05 129.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 122.6 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Laryngitis | 86 | 156.9 128.0–192.3ROR 170.6 · χ² 13,068 / p <1e-300 | 150.5 EB05 125.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=86 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Foot deformity | 82 | 146.3 118.7–180.2ROR 158.4 · χ² 11,605 / p <1e-300 | 140.5 EB05 116.8 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 119.3 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 81 | 144.6 117.2–178.4ROR 156.4 · χ² 11,327 / p <1e-300 | 138.9 EB05 115.3 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious PRR 115.1 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Pericarditis | 121 | 143.7 121.4–170.1ROR 162.0 · χ² 16,896 / p <1e-300 | 139.6 EB05 119.9 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 101.7 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Joint range of motion decreased | 96 | 142.2 117.4–172.2ROR 156.1 · χ² 13,226 / p <1e-300 | 137.3 EB05 115.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 127.2 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Hand deformity | 88 | 133.1 108.8–162.7ROR 144.9 · χ² 11,332 / p <1e-300 | 128.5 EB05 107.5 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 101.6 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Prescribed underdose | 134 | 132.9 113.4–155.8ROR 151.9 · χ² 17,310 / p <1e-300 | 129.6 EB05 112.2 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 159.6 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Sciatica | 98 | 122.2 101.1–147.6ROR 134.4 · χ² 11,593 / p <1e-300 | 118.7 EB05 100.2 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 115.4 · ♀ 98% (drug 65%) · 95% clinician | no trial data cached |
| Prescribed overdose | 96 | 98.0 80.9–118.6ROR 107.6 · χ² 9,080 / p <1e-300 | 95.7 EB05 80.7 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.6 · ♀ 99% (drug 65%) · 94% clinician | no trial data cached |
| Hip arthroplasty | 75 | 97.5 78.4–121.4ROR 104.8 · χ² 7,039 / p <1e-300 | 94.8 EB05 78.1 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.8 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Wound | 135 | 95.9 81.9–112.3ROR 109.6 · χ² 12,536 / p <1e-300 | 94.2 EB05 81.6 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.3 · ♀ 100% (drug 65%) · 99% clinician | no trial data cached |
| Irritable bowel syndrome | 102 | 94.3 78.3–113.4ROR 104.1 · χ² 9,283 / p <1e-300 | 92.2 EB05 78.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 84.2 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Synovitis | 86 | 94.1 76.8–115.3ROR 102.2 · χ² 7,796 / p <1e-300 | 91.8 EB05 76.6 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.3 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Fibromyalgia | 115 | 93.5 78.6–111.2ROR 104.7 · χ² 10,392 / p <1e-300 | 91.7 EB05 78.4 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 86.5 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Pulmonary fibrosis | 89 | 91.9 75.3–112.2ROR 100.2 · χ² 7,884 / p <1e-300 | 89.8 EB05 75.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 65.4 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Lower limb fracture | 88 | 91.0 74.4–111.2ROR 99.1 · χ² 7,712 / p <1e-300 | 88.9 EB05 74.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.5 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Hepatic cirrhosis | 85 | 89.8 73.2–110.1ROR 97.5 · χ² 7,346 / p <1e-300 | 87.7 EB05 73.1 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 64.0 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Type 2 diabetes mellitus | 149 | 87.1 75.0–101.1ROR 101.1 · χ² 12,556 / p <1e-300 | 85.8 EB05 74.8 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 64.6 · ♀ 99% (drug 65%) · 95% clinician | no trial data cached |
| Liver function test increased | 88 | 81.4 66.6–99.5ROR 88.6 · χ² 6,888 / p <1e-300 | 79.7 EB05 66.7 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 89.5 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Liver injury | 98 | 80.0 66.2–96.6ROR 87.9 · χ² 7,540 / p <1e-300 | 78.5 EB05 66.3 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.4 · ♀ 99% (drug 65%) · 95% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 90 | 79.4 65.1–96.8ROR 86.7 · χ² 6,870 / p <1e-300 | 77.8 EB05 65.3 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 81.0 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Joint stiffness | 97 | 72.9 60.3–88.2ROR 80.1 · χ² 6,791 / p <1e-300 | 71.7 EB05 60.5 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 93.4 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Disability | 67 | 66.8 52.9–84.2ROR 71.2 · χ² 4,264 / p <1e-300 | 65.4 EB05 53.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.4 · ♀ 98% (drug 65%) · 95% clinician | no trial data cached |
| C-reactive protein increased | 120 | 65.1 54.9–77.0ROR 73.2 · χ² 7,492 / p <1e-300 | 64.2 EB05 55.1 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious PRR 47.7 · 97% clinician | no trial data cached |
| Osteoarthritis | 135 | 62.7 53.5–73.4ROR 71.6 · χ² 8,120 / p <1e-300 | 61.9 EB05 53.7 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.5 · ♀ 98% (drug 65%) · 93% clinician | no trial data cached |
| Knee arthroplasty | 65 | 61.5 48.5–77.8ROR 65.4 · χ² 3,797 / p <1e-300 | 60.2 EB05 48.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.1 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Ear infection | 78 | 57.9 46.8–71.7ROR 62.4 · χ² 4,299 / p <1e-300 | 57.0 EB05 47.1 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.6 · ♀ 99% (drug 65%) · 96% clinician | no trial data cached |
| Impaired healing | 95 | 57.0 47.0–69.1ROR 62.5 · χ² 5,165 / p <1e-300 | 56.2 EB05 47.4 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 48.6 · ♀ 99% (drug 65%) · 96% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 133 | 56.8 48.4–66.6ROR 64.7 · χ² 7,229 / p <1e-300 | 56.2 EB05 48.6 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 68.2 · ♀ 98% (drug 65%) · 95% clinician | no trial data cached |
| Gait inability | 94 | 56.0 46.1–67.9ROR 61.3 · χ² 5,013 / p <1e-300 | 55.2 EB05 46.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.1 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Osteoporosis | 113 | 54.1 45.4–64.4ROR 60.4 · χ² 5,828 / p <1e-300 | 53.5 EB05 45.7 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.1 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Systemic lupus erythematosus | 96 | 53.5 44.2–64.7ROR 58.7 · χ² 4,886 / p <1e-300 | 52.8 EB05 44.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.7 · ♀ 100% (drug 65%) · 94% clinician | no trial data cached |
| Delirium | 89 | 50.7 41.6–61.9ROR 55.2 · χ² 4,283 / p <1e-300 | 50.1 EB05 41.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.4 · ♀ 97% (drug 65%) · 92% 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 |
|---|---|---|---|---|---|---|
| Weight increased (weight gain) | 162 | 14.3 12.4–16.5ROR 16.7 · χ² 2,011 / p <1e-300 | 14.2 EB05 12.5 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.6 · ♀ 99% (drug 65%) · 96% clinician | no trial data cached |
| Nasopharyngitis (common cold) | 155 | 16.5 14.3–19.1ROR 19.1 · χ² 2,260 / p <1e-300 | 16.5 EB05 14.4 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.0 · ♀ 97% (drug 65%) | no trial data cached |
| Type 2 diabetes mellitus | 149 | 87.1 75.0–101.1ROR 101.1 · χ² 12,556 / p <1e-300 | 85.8 EB05 74.8 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 64.6 · ♀ 99% (drug 65%) · 95% clinician | no trial data cached |
| Urticaria (hives) | 146 | 17.3 14.8–20.1ROR 19.8 · χ² 2,235 / p <1e-300 | 17.2 EB05 15.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.1 · ♀ 98% (drug 65%) · 96% clinician | no trial data cached |
| Peripheral swelling | 146 | 18.7 16.1–21.8ROR 21.5 · χ² 2,446 / p <1e-300 | 18.7 EB05 16.2 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.0 · ♀ 96% (drug 65%) | no trial data cached |
| Wound infection | 139 | 254.6 217.8–297.6ROR 292.6 · χ² 34,423 / p <1e-300 | 242.9 EB05 210.9 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 190.5 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Osteoarthritis | 135 | 62.7 53.5–73.4ROR 71.6 · χ² 8,120 / p <1e-300 | 61.9 EB05 53.7 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.5 · ♀ 98% (drug 65%) · 93% clinician | no trial data cached |
| Wound | 135 | 95.9 81.9–112.3ROR 109.6 · χ² 12,536 / p <1e-300 | 94.2 EB05 81.6 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.3 · ♀ 100% (drug 65%) · 99% clinician | no trial data cached |
| Wheezing | 134 | 44.6 38.1–52.3ROR 50.9 · χ² 5,672 / p <1e-300 | 44.3 EB05 38.3 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.4 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Prescribed underdose | 134 | 132.9 113.4–155.8ROR 151.9 · χ² 17,310 / p <1e-300 | 129.6 EB05 112.2 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 159.6 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 133 | 56.8 48.4–66.6ROR 64.7 · χ² 7,229 / p <1e-300 | 56.2 EB05 48.6 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 68.2 · ♀ 98% (drug 65%) · 95% clinician | no trial data cached |
| Pain in extremity | 129 | 8.6 7.3–10.1ROR 9.6 · χ² 870 / p 2e-191 | 8.4 EB05 7.3 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.5 · ♀ 96% (drug 65%) · 95% clinician | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 126 | 20.3 17.2–23.9ROR 22.8 · χ² 2,299 / p <1e-300 | 20.2 EB05 17.4 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 · ♀ 97% (drug 65%) | no trial data cached |
| Musculoskeletal stiffness | 125 | 28.1 23.8–33.1ROR 31.6 · χ² 3,244 / p <1e-300 | 27.9 EB05 24.0 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.4 · ♀ 100% (drug 65%) | no trial data cached |
| Visual impairment | 124 | 19.8 16.8–23.4ROR 22.3 · χ² 2,209 / p <1e-300 | 19.8 EB05 17.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.9 · ♀ 100% (drug 65%) · 97% 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 Clear Mint and Gel Toothpaste?
In FDA FAERS, the most frequently co-reported reaction terms for Clear Mint and Gel Toothpaste are weight increased, nasopharyngitis, type 2 diabetes mellitus, urticaria, peripheral swelling, wound infection. 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 Clear Mint and Gel Toothpaste have an FDA boxed warning?
No. The FDA label retrieved for Clear Mint and Gel Toothpaste has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Clear Mint and Gel Toothpaste 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 1be193b6-4c07-4f0a-e063-6394a90a32c7, effective 20240627; matched on
openfda.generic_name.exact:"CLEAR MINT, GEL TOOTHPASTE") - 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, 131 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.