POTASSIUM NITRATE, SODIUM FLUORIDE

N/A

Manufactured by Haleon US Holdings LLC

1,087 FDA adverse event reports analyzed

Last updated: 2026-04-15

About POTASSIUM NITRATE, SODIUM FLUORIDE

POTASSIUM NITRATE, 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, SODIUM FLUORIDE include DRUG INEFFECTIVE, DRUG EFFECTIVE FOR UNAPPROVED INDICATION, PRODUCT USE IN UNAPPROVED INDICATION, HYPERAESTHESIA TEETH, ORAL DISCOMFORT. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for POTASSIUM NITRATE, SODIUM FLUORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE161 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION59 reports
PRODUCT USE IN UNAPPROVED INDICATION59 reports
HYPERAESTHESIA TEETH56 reports
ORAL DISCOMFORT48 reports
DRUG EFFECT LESS THAN EXPECTED42 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE42 reports
CONDITION AGGRAVATED36 reports
ORAL MUCOSAL EXFOLIATION22 reports
TOOTHACHE19 reports
ORAL PAIN18 reports
GINGIVAL PAIN17 reports
STOMATITIS16 reports
THERAPEUTIC RESPONSE UNEXPECTED16 reports
TONGUE DISCOMFORT14 reports
HYPERSENSITIVITY12 reports
PRODUCT COMPLAINT12 reports
TOOTH DISCOLOURATION12 reports
DYSGEUSIA11 reports
GINGIVAL DISCOMFORT11 reports
GLOSSODYNIA11 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION11 reports
COUGH10 reports
DRY MOUTH9 reports
LIP SWELLING9 reports
BURN ORAL CAVITY8 reports
CHOKING7 reports
GINGIVAL BLEEDING7 reports
LIP EXFOLIATION7 reports
NASOPHARYNGITIS7 reports
NONINFECTIVE GINGIVITIS7 reports
PAIN IN EXTREMITY7 reports
PARAESTHESIA7 reports
PERIPHERAL SWELLING7 reports
RHINORRHOEA7 reports
ARTHRALGIA6 reports
DYSPHONIA6 reports
EAR PAIN6 reports
EXPIRED PRODUCT ADMINISTERED6 reports
GINGIVAL SWELLING6 reports
HYPOAESTHESIA ORAL6 reports
NASAL CONGESTION6 reports
OFF LABEL USE6 reports
OROPHARYNGEAL PAIN6 reports
SINUSITIS6 reports
SNEEZING6 reports
THROAT IRRITATION6 reports
TOOTH DISORDER6 reports
ACCIDENTAL EXPOSURE TO PRODUCT5 reports
BACK PAIN5 reports
COVID 195 reports
GINGIVAL DISORDER5 reports
JOINT SWELLING5 reports
KNEE ARTHROPLASTY5 reports
LIGAMENTUM FLAVUM HYPERTROPHY5 reports
MOUTH SWELLING5 reports
NAUSEA5 reports
ORAL CANDIDIASIS5 reports
OSTEOARTHROPATHY5 reports
PAIN5 reports
PARAESTHESIA ORAL5 reports
PNEUMONIA5 reports
SINUS PAIN5 reports
SPINAL OSTEOARTHRITIS5 reports
SPINAL STENOSIS5 reports
TOE OPERATION5 reports
VERTEBRAL LATERAL RECESS STENOSIS5 reports
DENTAL DISCOMFORT4 reports
DERMATITIS CONTACT4 reports
DYSPEPSIA4 reports
FATIGUE4 reports
LIP PAIN4 reports
MALAISE4 reports
PRODUCT PACKAGE ASSOCIATED INJURY4 reports
PRODUCT QUALITY ISSUE4 reports
RHINALGIA4 reports
SWELLING FACE4 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS4 reports
AGEUSIA3 reports
ASTHENIA3 reports
CHAPPED LIPS3 reports
CHEILITIS3 reports
CIRCADIAN RHYTHM SLEEP DISORDER3 reports
DIARRHOEA3 reports
DRUG HYPERSENSITIVITY3 reports
ERYTHEMA3 reports
GINGIVAL ERYTHEMA3 reports
GLOSSITIS3 reports
HAEMORRHAGE3 reports
ILL DEFINED DISORDER3 reports
ILLNESS3 reports
LIP BLISTER3 reports
LIP DRY3 reports
MOUTH ULCERATION3 reports
ORAL DISORDER3 reports
ORAL MUCOSAL ERYTHEMA3 reports
OROPHARYNGEAL DISCOMFORT3 reports
PAIN IN JAW3 reports
PRODUCT RESIDUE PRESENT3 reports
PRODUCT USE ISSUE3 reports

Report Outcomes

Out of 634 classified reports for POTASSIUM NITRATE, SODIUM FLUORIDE:

Serious 15.5%Non-Serious 84.5%

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

Female162 (76.4%)
Male50 (23.6%)

Reports by Age

Age 636 reports
Age 686 reports
Age 706 reports
Age 786 reports
Age 595 reports
Age 755 reports
Age 765 reports
Age 654 reports
Age 383 reports
Age 453 reports
Age 543 reports
Age 563 reports
Age 603 reports
Age 643 reports
Age 693 reports
Age 743 reports
Age 302 reports
Age 342 reports
Age 402 reports
Age 462 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, SODIUM FLUORIDE?

This profile reflects 1,087 FDA FAERS reports that mention POTASSIUM NITRATE, 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, SODIUM FLUORIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DRUG EFFECTIVE FOR UNAPPROVED INDICATION, PRODUCT USE IN UNAPPROVED INDICATION, HYPERAESTHESIA TEETH, ORAL DISCOMFORT, DRUG EFFECT LESS THAN EXPECTED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures POTASSIUM NITRATE, SODIUM FLUORIDE?

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