SODIUM MONOFLUOROPHOSPHATE

N/A

Manufactured by Haleon US Holdings LLC

998 FDA adverse event reports analyzed

Last updated: 2026-04-15

About SODIUM MONOFLUOROPHOSPHATE

SODIUM MONOFLUOROPHOSPHATE 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 SODIUM MONOFLUOROPHOSPHATE include FATIGUE, DYSPNOEA, NAUSEA, DIARRHOEA, MALAISE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SODIUM MONOFLUOROPHOSPHATE.

Top Adverse Reactions

FATIGUE38 reports
DYSPNOEA29 reports
NAUSEA29 reports
DIARRHOEA27 reports
MALAISE23 reports
VOMITING23 reports
DRY MOUTH20 reports
PAIN20 reports
CONSTIPATION18 reports
ORAL PAIN18 reports
HEADACHE17 reports
PYREXIA17 reports
RASH16 reports
DRUG INEFFECTIVE15 reports
STOMATITIS15 reports
WEIGHT DECREASED15 reports
DEPRESSION14 reports
DIZZINESS14 reports
PAIN IN EXTREMITY14 reports
PNEUMONIA14 reports
ARTHRALGIA13 reports
ASTHENIA13 reports
CHEST PAIN13 reports
DECREASED APPETITE13 reports
PRURITUS13 reports
COUGH12 reports
DYSGEUSIA12 reports
DYSPHAGIA12 reports
ERYTHEMA12 reports
INSOMNIA12 reports
GLOSSODYNIA11 reports
ORAL DISCOMFORT11 reports
ABDOMINAL PAIN10 reports
CHEST DISCOMFORT10 reports
CONFUSIONAL STATE10 reports
FALL10 reports
FEBRILE NEUTROPENIA10 reports
HYPERSENSITIVITY10 reports
LETHARGY10 reports
INJECTION SITE PAIN9 reports
SWOLLEN TONGUE9 reports
ABDOMINAL PAIN UPPER8 reports
BACK PAIN8 reports
DYSPEPSIA8 reports
GINGIVAL BLEEDING8 reports
PARAESTHESIA8 reports
TACHYCARDIA8 reports
TREMOR8 reports
ANXIETY7 reports
ATRIAL FIBRILLATION7 reports
BLOOD GLUCOSE INCREASED7 reports
BURNING SENSATION7 reports
DEATH7 reports
DEHYDRATION7 reports
DENTAL CARIES7 reports
FEELING ABNORMAL7 reports
GASTROOESOPHAGEAL REFLUX DISEASE7 reports
HYPOTENSION7 reports
INFECTION7 reports
LIP SWELLING7 reports
OROPHARYNGEAL PAIN7 reports
PULMONARY EMBOLISM7 reports
SOMNOLENCE7 reports
STRESS7 reports
THROMBOCYTOPENIA7 reports
TOOTH LOSS7 reports
ALOPECIA6 reports
ANAEMIA6 reports
ANAPHYLACTIC REACTION6 reports
CHOLECYSTITIS6 reports
EPISTAXIS6 reports
GAIT DISTURBANCE6 reports
HYPERTENSION6 reports
HYPOPHAGIA6 reports
LIP DRY6 reports
NASOPHARYNGITIS6 reports
ORAL DISORDER6 reports
THROAT IRRITATION6 reports
TOOTH FRACTURE6 reports
TOOTHACHE6 reports
WHITE BLOOD CELL COUNT DECREASED6 reports
BLOOD PRESSURE INCREASED5 reports
BRONCHITIS5 reports
CHILLS5 reports
CONTUSION5 reports
DEEP VEIN THROMBOSIS5 reports
DRY SKIN5 reports
FLATULENCE5 reports
GINGIVAL PAIN5 reports
GINGIVITIS5 reports
HYPOAESTHESIA5 reports
JOINT SWELLING5 reports
MOUTH SWELLING5 reports
MUCOSAL INFLAMMATION5 reports
MUSCULOSKELETAL DISCOMFORT5 reports
NEUTROPHIL COUNT DECREASED5 reports
OSTEONECROSIS OF JAW5 reports
PAIN IN JAW5 reports
PRODUCT FORMULATION ISSUE5 reports
SENSITIVITY OF TEETH5 reports

Report Outcomes

Out of 333 classified reports for SODIUM MONOFLUOROPHOSPHATE:

Serious 67.9%Non-Serious 32.1%

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

Female229 (71.8%)
Male88 (27.6%)
Unknown2 (0.6%)

Reports by Age

Age 7711 reports
Age 669 reports
Age 488 reports
Age 578 reports
Age 788 reports
Age 547 reports
Age 627 reports
Age 677 reports
Age 586 reports
Age 656 reports
Age 686 reports
Age 696 reports
Age 746 reports
Age 495 reports
Age 595 reports
Age 635 reports
Age 705 reports
Age 725 reports
Age 735 reports
Age 755 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 SODIUM MONOFLUOROPHOSPHATE?

This profile reflects 998 FDA FAERS reports that mention SODIUM MONOFLUOROPHOSPHATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SODIUM MONOFLUOROPHOSPHATE?

Frequently reported terms in FAERS include FATIGUE, DYSPNOEA, NAUSEA, DIARRHOEA, MALAISE, VOMITING. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures SODIUM MONOFLUOROPHOSPHATE?

Labeling and FAERS entries often list Haleon US Holdings LLC in connection with SODIUM MONOFLUOROPHOSPHATE. 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.