65/100 · Elevated
Manufactured by Rising Pharma Holdings, Inc.
Moderate Safety Concerns with Sodium Fluoride
14,056 FDA adverse event reports analyzed
Last updated: 2026-05-12
SODIUM FLUORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Rising Pharma Holdings, Inc.. Based on analysis of 14,056 FDA adverse event reports, SODIUM FLUORIDE has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for SODIUM FLUORIDE include FATIGUE, NAUSEA, PAIN, DIARRHOEA, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SODIUM FLUORIDE.
Sodium Fluoride has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 14,056 adverse event reports for this medication, which is primarily manufactured by Rising Pharma Holdings, Inc..
The most commonly reported adverse events include Fatigue, Nausea, Pain. Of classified reports, 65.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue, nausea, and pain are the most frequently reported adverse events.
Serious adverse events, such as pneumonia and weight decreased, account for a significant portion of reports. A diverse range of reactions, including respiratory and musculoskeletal issues, are reported. Weight changes (increase and decrease) are notable among the adverse events.
Patients taking Sodium Fluoride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. No specific drug interactions are noted, but caution should be exercised in patients with pre-existing respiratory or musculoskeletal conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sodium Fluoride received a safety concern score of 65/100 (elevated concern). This is based on a 65.4% serious event ratio across 3,574 classified reports. The score accounts for 14,056 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 2,071, Male: 1,148, Unknown: 15. The most frequently reported age groups are age 74 (71 reports), age 72 (67 reports), age 66 (55 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 3,574 classified reports for SODIUM FLUORIDE:
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 reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
No specific drug interactions are noted, but caution should be exercised in patients with pre-existing respiratory or musculoskeletal conditions.
If you are taking Sodium Fluoride, here are important things to know. The most commonly reported side effects include fatigue, nausea, pain, diarrhoea, vomiting. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of respiratory infections and musculoskeletal pain, especially in elderly patients. Report any significant changes in weight to your healthcare provider. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of sodium fluoride. Patients should report any adverse events to their healthcare provider.
The FDA has received approximately 14,056 adverse event reports associated with Sodium Fluoride. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Sodium Fluoride include Fatigue, Nausea, Pain, Diarrhoea, Vomiting. By volume, the top reported reactions are: Fatigue (340 reports), Nausea (312 reports), Pain (281 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Sodium Fluoride.
Out of 3,574 classified reports, 2,337 (65.4%) were classified as serious and 1,237 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Sodium Fluoride break down by patient sex as follows: Female: 2,071, Male: 1,148, Unknown: 15. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Sodium Fluoride adverse events are: age 74: 71 reports, age 72: 67 reports, age 66: 55 reports, age 68: 54 reports, age 64: 51 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Sodium Fluoride adverse event reports is Rising Pharma Holdings, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Sodium Fluoride include: Pyrexia, Pneumonia, Dizziness, Headache, Weight Decreased. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Sodium Fluoride to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Sodium Fluoride has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Fatigue, nausea, and pain are the most frequently reported adverse events.
Key safety signals identified in Sodium Fluoride's adverse event data include: Pneumonia and weight decreased are serious adverse events.. A high number of musculoskeletal and respiratory reactions are reported.. A diverse range of reactions, including neurological and gastrointestinal issues, are observed.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
No specific drug interactions are noted, but caution should be exercised in patients with pre-existing respiratory or musculoskeletal conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sodium Fluoride.
Monitor for signs of respiratory infections and musculoskeletal pain, especially in elderly patients. Report any significant changes in weight to your healthcare provider.
Sodium Fluoride has 14,056 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and weight decreased, account for a significant portion of reports. The volume of reports for Sodium Fluoride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of sodium fluoride. Patients should report any adverse events to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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