STANNOUS FLUORIDE: 438 Adverse Event Reports & Safety Profile
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Route: DENTAL · Manufacturer: Colgate-Palmolive Company · HUMAN OTC DRUG · FDA Label: Available
First Report: 19700101 · Latest Report: 20250905
What Are the Most Common STANNOUS FLUORIDE Side Effects?
All STANNOUS FLUORIDE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Oral discomfort | 67 | 15.3% | 1 | 2 |
| Oral pain | 44 | 10.1% | 0 | 0 |
| Stomatitis | 38 | 8.7% | 0 | 0 |
| Drug ineffective | 34 | 7.8% | 0 | 1 |
| Gingival pain | 33 | 7.5% | 0 | 0 |
| Toothache | 33 | 7.5% | 0 | 0 |
| Lip swelling | 32 | 7.3% | 1 | 3 |
| Oral mucosal exfoliation | 29 | 6.6% | 0 | 0 |
| Product use in unapproved indication | 23 | 5.3% | 0 | 0 |
| Hypersensitivity | 22 | 5.0% | 0 | 4 |
| Glossodynia | 21 | 4.8% | 0 | 0 |
| Burn oral cavity | 19 | 4.3% | 0 | 0 |
| Cheilitis | 19 | 4.3% | 0 | 0 |
| Condition aggravated | 18 | 4.1% | 0 | 0 |
| Drug effective for unapproved indication | 18 | 4.1% | 0 | 0 |
| Dry mouth | 18 | 4.1% | 0 | 1 |
| Hypoaesthesia oral | 18 | 4.1% | 0 | 0 |
| Lip pain | 18 | 4.1% | 0 | 0 |
| Swollen tongue | 18 | 4.1% | 0 | 5 |
| Gingival discomfort | 17 | 3.9% | 0 | 0 |
Who Reports STANNOUS FLUORIDE Side Effects? Age & Gender Data
Gender: 71.1% female, 28.9% male. Average age: 54.3 years. Most reports from: US. View detailed demographics →
Is STANNOUS FLUORIDE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 0 |
| 2003 | 1 | 0 | 0 |
| 2009 | 1 | 0 | 0 |
| 2012 | 1 | 0 | 0 |
| 2013 | 1 | 0 | 0 |
| 2014 | 7 | 0 | 0 |
| 2015 | 12 | 0 | 0 |
| 2016 | 24 | 0 | 0 |
| 2017 | 16 | 0 | 3 |
| 2018 | 27 | 1 | 1 |
| 2019 | 23 | 0 | 1 |
| 2020 | 8 | 0 | 0 |
| 2021 | 7 | 0 | 0 |
| 2022 | 10 | 0 | 0 |
| 2023 | 5 | 0 | 0 |
| 2024 | 33 | 0 | 0 |
| 2025 | 9 | 0 | 3 |
What Is STANNOUS FLUORIDE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 136 |
| Hyperaesthesia teeth | 45 |
| Dental disorder prophylaxis | 41 |
| Sensitivity of teeth | 33 |
| Dental cleaning | 28 |
| Dental care | 21 |
| Gingival bleeding | 12 |
| Gingival pain | 12 |
| Gingival disorder | 8 |
| Tooth whitening | 8 |
STANNOUS FLUORIDE vs Alternatives: Which Is Safer?
Official FDA Label for STANNOUS FLUORIDE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses aids in the prevention of dental cavities builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact When using this product, if irritation occurs discontinue use Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist pain/sensitivity still persists after 4 weeks of use Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Directions adults and children 12 years of age and older : apply at least a 1-inch strip of the product onto a soft bristle toothbrush brush teeth thoroughly for at least one minute twise a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. children under 12 years of age : Consult a dentist or doctor. Other information products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist this product is specifically formulated to prevent staining store below 30°C (86°F)
Dosage & Administration
Directions Do not use before mixing with water Use immediately after preparing the rinse Adults and children 6 years of age and older: Use as directed by a dental professional Use once a day after brushing your teeth with a toothpaste or as directed by your dentist Remove cap and seal and replace with pump Rotate spout counter clockwise to extend Depress pump until medicine comes to the tip of the pump Put 1/8 oz. (approx. 2 pump strokes) of concentrated Pro-DenRx Rinse into the provided mixing vial Add water to 1 oz. line on mixing vial Tightly snap on the cap and shake well Vigorously swish between your teeth 1/2 of mixture for one minute and then spit out Repeat procedure with remaining mixture Rinse mixing vial with water after use Do not swallow the rinse Do not eat or drink for 30 minutes after rinsing Children 6 to 12 years of age: Instruct children in good rinsing habits (to minimize swallowing) Supervise children as necessary until capable of using without supervision Children under 6 years of age: Consult a dentist or doctor For home irrigation Prepare 1 oz. of Pro-DenRx Rinse as described above Pour into irrigator reservoir, add 4 oz. of water and mix thoroughly Use irrigator as directed Rinse irrigator with water after use
Warnings
Warning Keep out of reach of children under 12 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Directions adults and children 12 yrs. of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. do not swallow children under 12 yrs. of age: ask a dentist Other information products containing stannous fluoride may produce surface staining of the teeth adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist see your dentist regularly Inactive ingredients glycerin, hydrated silica, water, zinc lactate, sodium lauryl sulfate, trisodium phosphate, flavor, sodium gluconate, sodium saccharin, xanthan gum, cellulose gum, sodium hydroxide, polyethylene, mica, titanium dioxide, blue 1
Active Ingredient
Active Ingredient Purpose Stannous fluoride 0.454% (0.15% w/v fluoride ion) .......................... Anticavity/Antihypersensitivity
Inactive Ingredients
Inactive ingredients Caprylic/Capric Triglyceride (Organic Coconut Oil), Isomalt, Hydrated Silica, Xylitol, Sorbitol, Sodium Bicarbonate, Erythritol, Sodium Lauroyl Sarcosinate, Flavor, Xanthan Gum, Menthol, PEG-40 Hydrogenated Castor Oil, Zinc Citrate, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint)
Leaf
Oil, Potassium Citrate, Siraitia Grosvenorii (Monkfruit)
Fruit
Extract, Sodium Saccharin, Potassium Bitartrate, Carbon Dioxide, Sodium Benzoate, Water, Maltodextrin, Carvone, Rebaudioside A, Alcohol Denat., Limonene, Sodium Chloride, Hydrolyzed Gardenia Florida Extract, Glycyrrhizic Acid, Gamma-Terpinene, Titanium Dioxide.