POTASSIUM NITRATE AND SODIUM FLUORIDE

N/A

Manufactured by Haleon US Holdings LLC

1,057 FDA adverse event reports analyzed

Last updated: 2026-04-15

About POTASSIUM NITRATE AND SODIUM FLUORIDE

POTASSIUM NITRATE AND SODIUM 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 POTASSIUM NITRATE AND SODIUM FLUORIDE include ORAL DISCOMFORT, DRUG INEFFECTIVE, HYPERAESTHESIA TEETH, TOOTHACHE, ORAL PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for POTASSIUM NITRATE AND SODIUM FLUORIDE.

Top Adverse Reactions

ORAL DISCOMFORT79 reports
DRUG INEFFECTIVE78 reports
HYPERAESTHESIA TEETH49 reports
TOOTHACHE40 reports
ORAL PAIN39 reports
PRODUCT COMPLAINT36 reports
ORAL MUCOSAL EXFOLIATION30 reports
PRODUCT USE IN UNAPPROVED INDICATION29 reports
CONDITION AGGRAVATED28 reports
GINGIVAL PAIN22 reports
STOMATITIS21 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION20 reports
HYPERSENSITIVITY20 reports
TONGUE DISCOMFORT18 reports
BURN ORAL CAVITY17 reports
EXPIRED PRODUCT ADMINISTERED16 reports
GINGIVAL BLEEDING16 reports
GINGIVAL DISCOMFORT15 reports
DYSGEUSIA12 reports
LIP SWELLING12 reports
THROAT IRRITATION12 reports
TOOTH DISCOLOURATION11 reports
ACCIDENTAL EXPOSURE TO PRODUCT10 reports
DRUG EFFECT LESS THAN EXPECTED10 reports
DRY MOUTH10 reports
NONINFECTIVE GINGIVITIS10 reports
CHOKING9 reports
DENTAL DISCOMFORT9 reports
GLOSSODYNIA9 reports
PAIN9 reports
TOOTH INJURY9 reports
LIP DRY8 reports
OROPHARYNGEAL PAIN8 reports
POOR QUALITY PRODUCT ADMINISTERED8 reports
RETCHING8 reports
TOOTH DISORDER8 reports
COUGH7 reports
DERMATITIS CONTACT7 reports
DIARRHOEA7 reports
GINGIVAL DISORDER7 reports
LIP PAIN7 reports
NAUSEA7 reports
PARAESTHESIA ORAL7 reports
PRODUCT PACKAGE ASSOCIATED INJURY7 reports
PRODUCT QUALITY ISSUE7 reports
SWELLING FACE7 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS7 reports
CHEILITIS6 reports
DENTAL CARIES6 reports
GINGIVAL SWELLING6 reports
GLOSSITIS6 reports
MOUTH SWELLING6 reports
ORAL MUCOSAL BLISTERING6 reports
THERAPEUTIC RESPONSE UNEXPECTED6 reports
COATING IN MOUTH5 reports
DISCOMFORT5 reports
DYSPNOEA5 reports
HAEMORRHAGE5 reports
HYPOAESTHESIA ORAL5 reports
ILLNESS5 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION5 reports
MOUTH ULCERATION5 reports
OFF LABEL USE5 reports
ORAL MUCOSAL ERYTHEMA5 reports
PHARYNGEAL OEDEMA5 reports
PRODUCT USE ISSUE5 reports
SALIVARY HYPERSECRETION5 reports
SEIZURE5 reports
SWOLLEN TONGUE5 reports
VOMITING5 reports
ABDOMINAL DISCOMFORT4 reports
ACCIDENTAL DEVICE INGESTION4 reports
ADVERSE DRUG REACTION4 reports
APHTHOUS ULCER4 reports
BURNING SENSATION4 reports
CHAPPED LIPS4 reports
CHEMICAL BURN OF GASTROINTESTINAL TRACT4 reports
DIZZINESS4 reports
DRUG DEPENDENCE4 reports
DYSPEPSIA4 reports
DYSPHAGIA4 reports
EXPOSURE DURING PREGNANCY4 reports
HEADACHE4 reports
ILL DEFINED DISORDER4 reports
LIP EXFOLIATION4 reports
MALAISE4 reports
ORAL DISORDER4 reports
ORAL MUCOSAL ERUPTION4 reports
PAIN IN JAW4 reports
SENSITIVITY OF TEETH4 reports
SKIN EXFOLIATION4 reports
TONGUE BLISTERING4 reports
WEIGHT DECREASED4 reports
AGEUSIA3 reports
ANAPHYLACTIC REACTION3 reports
BLISTER3 reports
CEREBROVASCULAR ACCIDENT3 reports
COELIAC DISEASE3 reports
DEATH3 reports
DRUG HYPERSENSITIVITY3 reports

Report Outcomes

Out of 579 classified reports for POTASSIUM NITRATE AND SODIUM FLUORIDE:

Serious 27.1%Non-Serious 72.9%

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

Female215 (68.3%)
Male100 (31.7%)

Reports by Age

Age 566 reports
Age 636 reports
Age 736 reports
Age 776 reports
Age 786 reports
Age 365 reports
Age 495 reports
Age 705 reports
Age 755 reports
Age 304 reports
Age 384 reports
Age 454 reports
Age 474 reports
Age 504 reports
Age 544 reports
Age 554 reports
Age 584 reports
Age 604 reports
Age 654 reports
Age 664 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 POTASSIUM NITRATE AND SODIUM FLUORIDE?

This profile reflects 1,057 FDA FAERS reports that mention POTASSIUM NITRATE AND SODIUM FLUORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for POTASSIUM NITRATE AND SODIUM FLUORIDE?

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

Who manufactures POTASSIUM NITRATE AND SODIUM FLUORIDE?

Labeling and FAERS entries often list Haleon US Holdings LLC in connection with POTASSIUM NITRATE AND SODIUM 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.