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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

POTASSIUM\SODIUM FLUORIDE: 1,004 Adverse Event Reports & Safety Profile

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1,004
Total FAERS Reports
3 (0.3%)
Deaths Reported
15
Hospitalizations
1,004
As Primary/Secondary Suspect
1
Life-Threatening
11
Disabilities

Active Ingredient: POTASSIUM NITRATE\SODIUM FLUORIDE ·

First Report: 1999 · Latest Report: 20250615

What Are the Most Common POTASSIUM\SODIUM FLUORIDE Side Effects?

#1 Most Reported
Drug ineffective
204 reports (20.3%)
#2 Most Reported
Oral discomfort
100 reports (10.0%)
#3 Most Reported
Hyperaesthesia teeth
88 reports (8.8%)

All POTASSIUM\SODIUM FLUORIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 204 20.3% 0 1
Oral discomfort 100 10.0% 1 1
Hyperaesthesia teeth 88 8.8% 0 0
Product use in unapproved indication 77 7.7% 0 0
Drug effective for unapproved indication 72 7.2% 0 0
Condition aggravated 55 5.5% 0 1
Toothache 55 5.5% 0 1
Drug effect less than expected 47 4.7% 0 0
Oral pain 47 4.7% 0 1
Oral mucosal exfoliation 46 4.6% 0 0
Therapeutic product effect incomplete 46 4.6% 0 0
Product complaint 41 4.1% 0 0
Gingival pain 30 3.0% 0 0
Stomatitis 30 3.0% 0 0
Hypersensitivity 29 2.9% 0 0
Tongue discomfort 24 2.4% 0 0
Tooth discolouration 22 2.2% 0 0
Gingival discomfort 21 2.1% 0 1
Dysgeusia 19 1.9% 0 0
Therapeutic response unexpected 19 1.9% 0 0

Who Reports POTASSIUM\SODIUM FLUORIDE Side Effects? Age & Gender Data

Gender: 74.1% female, 25.9% male. Average age: 59.7 years. Most reports from: US. View detailed demographics →

Is POTASSIUM\SODIUM FLUORIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 1 0 0
2010 1 0 0
2011 1 0 0
2013 2 0 0
2014 10 0 2
2015 11 0 1
2016 10 1 0
2017 6 0 0
2018 10 0 0
2019 11 0 0
2020 9 0 0
2021 12 0 1
2022 12 0 0
2023 3 0 0
2024 69 0 1
2025 20 0 0

View full timeline →

What Is POTASSIUM\SODIUM FLUORIDE Used For?

IndicationReports
Product used for unknown indication 498
Hyperaesthesia teeth 194
Tooth whitening 118
Dental cleaning 56
Dental disorder prophylaxis 56
Dental care 29
Gingival pain 29
Sensitivity of teeth 24
Gingival bleeding 10
Toothache 10

POTASSIUM\SODIUM FLUORIDE vs Alternatives: Which Is Safer?

POTASSIUM\SODIUM FLUORIDE vs POVIDONE-IODINE POTASSIUM\SODIUM FLUORIDE vs PRABOTULINUMTOXINA-XVFS POTASSIUM\SODIUM FLUORIDE vs PRADAXA POTASSIUM\SODIUM FLUORIDE vs PRALATREXATE POTASSIUM\SODIUM FLUORIDE vs PRALSETINIB POTASSIUM\SODIUM FLUORIDE vs PRAMIPEXOLE POTASSIUM\SODIUM FLUORIDE vs PRAMIPEXOLE\PRAMIPEXOLE POTASSIUM\SODIUM FLUORIDE vs PRAMLINTIDE POTASSIUM\SODIUM FLUORIDE vs PRASTERONE POTASSIUM\SODIUM FLUORIDE vs PRASUGREL

Official FDA Label for POTASSIUM\SODIUM FLUORIDE

Official prescribing information from the FDA-approved drug label.