STANNOUS FLUORIDE

N/A

Manufactured by Haleon US Holdings LLC

1,587 FDA adverse event reports analyzed

Last updated: 2026-04-15

About STANNOUS FLUORIDE

STANNOUS FLUORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. The most commonly reported adverse reactions for STANNOUS FLUORIDE include ORAL DISCOMFORT, DRUG INEFFECTIVE, ORAL PAIN, TOOTHACHE, STOMATITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for STANNOUS FLUORIDE.

Top Adverse Reactions

ORAL DISCOMFORT101 reports
DRUG INEFFECTIVE79 reports
ORAL PAIN51 reports
TOOTHACHE46 reports
STOMATITIS43 reports
GINGIVAL PAIN41 reports
ORAL MUCOSAL EXFOLIATION34 reports
LIP SWELLING33 reports
TOOTH DISCOLOURATION32 reports
CONDITION AGGRAVATED30 reports
AGEUSIA29 reports
DYSGEUSIA29 reports
GLOSSODYNIA29 reports
PRODUCT USE IN UNAPPROVED INDICATION28 reports
HYPERSENSITIVITY27 reports
GINGIVAL DISCOMFORT24 reports
HYPOAESTHESIA ORAL24 reports
HYPERAESTHESIA TEETH22 reports
BURN ORAL CAVITY21 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION21 reports
DRY MOUTH21 reports
TONGUE DISCOMFORT21 reports
CHEILITIS20 reports
COUGH18 reports
GINGIVAL BLEEDING18 reports
LIP PAIN18 reports
ORAL MUCOSAL BLISTERING18 reports
DYSPNOEA17 reports
SWOLLEN TONGUE17 reports
GINGIVAL DISORDER16 reports
GINGIVAL SWELLING16 reports
PRODUCT COMPLAINT16 reports
THROAT IRRITATION16 reports
NONINFECTIVE GINGIVITIS15 reports
PAIN15 reports
APHTHOUS ULCER14 reports
LIP DRY14 reports
CHOKING13 reports
DYSPHAGIA13 reports
ORAL DISORDER13 reports
OROPHARYNGEAL PAIN13 reports
ACCIDENTAL EXPOSURE TO PRODUCT12 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION12 reports
MALAISE12 reports
MOUTH ULCERATION12 reports
NAUSEA12 reports
TONGUE BLISTERING12 reports
MOUTH SWELLING11 reports
PARAESTHESIA ORAL11 reports
SENSITIVITY OF TEETH11 reports
TOOTH LOSS11 reports
CHEMICAL BURN OF GASTROINTESTINAL TRACT10 reports
FATIGUE10 reports
ORAL MUCOSAL ERYTHEMA10 reports
SWELLING FACE10 reports
TONGUE DISCOLOURATION10 reports
TOOTH DISORDER10 reports
BURNING SENSATION9 reports
DRUG EFFECT LESS THAN EXPECTED9 reports
DRUG HYPERSENSITIVITY9 reports
DYSPHONIA9 reports
GLOSSITIS9 reports
LIP ERYTHEMA9 reports
OFF LABEL USE9 reports
PRODUCT QUALITY ISSUE9 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE9 reports
TONGUE DISORDER9 reports
VOMITING9 reports
ANAPHYLACTIC REACTION8 reports
DERMATITIS CONTACT8 reports
DYSPEPSIA8 reports
ERYTHEMA8 reports
EXPIRED PRODUCT ADMINISTERED8 reports
FEEDING DISORDER8 reports
NASOPHARYNGITIS8 reports
PARAESTHESIA8 reports
RASH8 reports
RHINORRHOEA8 reports
TONGUE ULCERATION8 reports
ADVERSE DRUG REACTION7 reports
ARTHRALGIA7 reports
DENTAL DISCOMFORT7 reports
GINGIVAL ERYTHEMA7 reports
HYPOAESTHESIA7 reports
ORAL CANDIDIASIS7 reports
PAIN IN EXTREMITY7 reports
PERIPHERAL SWELLING7 reports
PNEUMONIA7 reports
THERAPEUTIC RESPONSE UNEXPECTED7 reports
TOOTH INJURY7 reports
WEIGHT DECREASED7 reports
COVID 196 reports
DEATH6 reports
DENTAL CARIES6 reports
DIARRHOEA6 reports
EAR PAIN6 reports
HAEMORRHAGE6 reports
HEADACHE6 reports
ILL DEFINED DISORDER6 reports
LIP EXFOLIATION6 reports

Report Outcomes

Out of 712 classified reports for STANNOUS FLUORIDE:

Serious 43.5%Non-Serious 56.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female316 (67.5%)
Male151 (32.3%)
Unknown1 (0.2%)

Reports by Age

Age 6613 reports
Age 6812 reports
Age 5211 reports
Age 5911 reports
Age 549 reports
Age 719 reports
Age 789 reports
Age 388 reports
Age 588 reports
Age 708 reports
Age 297 reports
Age 347 reports
Age 457 reports
Age 507 reports
Age 557 reports
Age 637 reports
Age 486 reports
Age 616 reports
Age 646 reports
Age 656 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with STANNOUS FLUORIDE?

This profile reflects 1,587 FDA FAERS reports that mention STANNOUS FLUORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for STANNOUS FLUORIDE?

Frequently reported terms in FAERS include ORAL DISCOMFORT, DRUG INEFFECTIVE, ORAL PAIN, TOOTHACHE, STOMATITIS, GINGIVAL PAIN. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures STANNOUS FLUORIDE?

Labeling and FAERS entries often list Haleon US Holdings LLC in connection with STANNOUS FLUORIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.