Sodium fluoride 10mg/5ml oral solution
Requires a prescription from a doctor or prescriber
Minerals
Safety information for pregnancy and breastfeeding
Breastfeeding
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Sodium fluoride
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Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Sodium fluoride
About EudraVigilance
Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
Part of the Fluoritop brand family (generic: Sodium fluoride)
MHRA licensed products
View all licensed products for Sodium fluoride on the MHRA register
WHO defined daily dose (DDD)
88 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via NHS dm+d BNF mapping files. Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Clinical guidelines and formulary information
British National Formulary
Sodium fluoride
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
3 to 10 hours
Mechanism
The prevention of dental caries by topical fluoride is achieved by various mechanisms.
Food interactions
1 warning
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
90%
Half-life
3 to 10 hours
[L7685]…
Protein binding
[A181652]
The percentage of protein binding is not readily available in the evaluated literature.
Volume of distribution
36%
[A181652]…
Metabolism
Elimination
90%
Clearance
11.2mL/min
[L7685]…
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
[A181652][L7670]
Fluoride supplements in the form of tablets and other formulas may be prescribed to prevent tooth decay in high-risk children aged 6 months to 16 years old whose drinking water source contains low fluoride concentrations.
[L7691]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 722 interactions
[L7679]
Overdose information
The ingestion of toothpaste is the major cause of sodium fluoride overdose. This is followed by sodium fluoride supplements and mouth rinses.
Most causes of sodium fluoride toxicity have been observed in children under the age of 6 years old.
[A181670]
The manifestations of a sodium fluoride overdose may include gastrointestinal disturbance, abdominal pain, alterations in taste, seizures, salivation, bradycardia, tachycardia, headache, tremor, and shallow breathing.
[L7676]
Gastrointestinal bleeding may also occur in addition to a sensation of burning in the mouth.
[L7670]
Hypotension, bronchospasm, fixed mydriasis, and elevated potassium can also occur which, in turn, may lead to arrhythmias and cardiac arrest.
[A181670]
Management
If a dose greater than 5 mg fluoride per kilogram of body weight (2.3 mg fluoride per pound of body weight) has been taken, it is advisable to induce vomiting. Administer calcium in an oral, soluble form (for example, 5% calcium gluconate, a solution of calcium lactate, or milk). The patient should seek immediate medical attention.
If a sodium fluoride ingestion of 15 mg fluoride/kg of body weight or more occurs (i.e. higher than 6.9 mg fluoride per pound), immediately induce vomiting, provide supportive care, and admit the patient to the hospital for observation.
[L7670]
When administered at low topical doses, fluoride in both saliva and plaque and saliva prevent the demineralization of healthy tooth enamel while remineralizing teeth that have previously been demineralized. Sodium fluoride is absorbed by the surface of hydroxyapatite crystals on the teeth, which are necessary for mineralization. This renders the teeth more resistant to demineralization by changing the apatite crystal solubility.[A181670][A181694] Sodium fluoride inhibits the demineralization of teeth in a pH-related manner. When used in high doses, in formulations such as the fluoride varnishes or gels, sodium fluoride forms a layer on the surface of tooth enamel. When the pH of the mouth is reduced due to acid production by bacteria such as S.mutans, fluoride is released, interfering with bacterial metabolism, and then acts to remineralize the teeth.[A181652][A181694][L7688]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[A181658]
Cmax was estimated to be 848 ± 116 ng/mL after a 20mg sodium fluoride solution was ingested, with a Tmax of 0.46 ± 0.17 hours.
[A181652]
The bioavailability of sodium fluoride tablets administered in the fasted state during one pharmacokinetic study approached 100%.
[A181658]
Another resource reports a sodium fluoride AUC of 1.14 ± 0.12 μg × h/mL after the ingestion of fluoridated water.
[A181664]
[L7685]
The half-life of sodium fluoride in the bones is 20 years.
[L7697]
[A181652]
The percentage of protein binding is not readily available in the evaluated literature.
[A181652]
After the ingestion of sodium fluoridated drinking water, the fluoride ions are found to distribute to the plasma and blood cells. Plasma levels of fluoride concentrations are twice as the concentrations found in blood cells.
[L7685]
Adults have been found to retain 36% of ingested fluoride and children have been found to retain about 50% of a dose. Most of the retained fluoride is localized to bone and teeth and 1% accumulates in soft tissues.
[A181652]
Fluoride crosses the placenta and the blood-brain barrier.
The central nervous system concentrations of sodium fluoride are estimated to reach 20% the plasma concentrations.
[L7685]
Studies conducted in communities with high levels of fluoride in water did not show any increase in birth defects.
[L7670]
The placenta is able to regulate the accumulation of excess fluoride, possibly protecting the fetus from high levels of fluoride.
[A181670]
Despite this, excessively high exposure to fluoride in utero may lead to skeletal fluorosis.
[L7670]
[A181652]
[A181652]
[L7685]
According to one clinical study evaluating the pharmacokinetics of oral sodium fluoride tablets in healthy young adults, the renal clearance was determined to be 77.4 ± 11.2mL/min for acidic urine and 78.4 ± 6.9mL/min for alkaline urine.
[A181658]
Another reference estimates the renal clearance of fluoride ions from sodium fluoridated water at 35–45 mL/min.
[A181664]
Enzymes involved in drug metabolism — important for understanding drug interactions
ATC A01AA51
ATC A01AA01
ATC A12CD01
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Show
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Sodium fluoride
Additional database identifiers
Drugs Product Database (DPD)
219
Drugs Product Database (DPD)
6416
Drugs Product Database (DPD)
11088
ChemSpider
5045
BindingDB
50209223
HUGO Gene Nomenclature Committee (HGNC)
HGNC:24599
GeneCards
ENOPH1
UniProt Accession
ENOPH_HUMAN
UniProt Accession
ENO_LACCB
UniProt Accession
ENO_STRSV
UniProt Accession
ENO_STRMU
Patent information
1 active patent
Source: DrugBank · CC BY-NC 4.0. Patent data sourced from national patent offices. Expiry dates may not reflect extensions, regulatory exclusivity periods, or legal challenges.
DrugBank citations
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