85/100 · Critical
Manufactured by Belleview Bioscience LLC
High Safety Concerns with Sodium Chloride Tablet Use
143,107 FDA adverse event reports analyzed
Last updated: 2026-05-12
SODIUM CHLORIDE TABLET is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Belleview Bioscience LLC. Based on analysis of 143,107 FDA adverse event reports, SODIUM CHLORIDE TABLET has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for SODIUM CHLORIDE TABLET include NAUSEA, MYELOSUPPRESSION, DYSPNOEA, OFF LABEL USE, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SODIUM CHLORIDE TABLET.
Sodium Chloride Tablet has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 143,107 adverse event reports for this medication, which is primarily manufactured by Belleview Bioscience Llc.
The most commonly reported adverse events include Nausea, Myelosuppression, Dyspnoea. Of classified reports, 80.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Severe reactions such as pneumonia, sepsis, and respiratory failure are common.
Significant drops in white blood cell count and platelet count are frequent. A high number of serious adverse events (80.9%) indicate potential risks. Multiple gastrointestinal and respiratory issues are reported.
Patients taking Sodium Chloride Tablet should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Sodium Chloride Tablet may interact with other medications, leading to adverse effects. It is important to consult a healthcare provider before use, especially in patients with pre-existing conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sodium Chloride Tablet received a safety concern score of 85/100 (high concern). This is based on a 80.9% serious event ratio across 67,828 classified reports. The score accounts for 143,107 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 36,060, Male: 25,647, Unknown: 69. The most frequently reported age groups are age 54 (1,010 reports), age 65 (1,001 reports), age 67 (995 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 67,828 classified reports for SODIUM CHLORIDE TABLET:
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.
Sodium Chloride Tablet may interact with other medications, leading to adverse effects. It is important to consult a healthcare provider before use, especially in patients with pre-existing conditions.
If you are taking Sodium Chloride Tablet, here are important things to know. The most commonly reported side effects include nausea, myelosuppression, dyspnoea, off label use, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow the prescribed dosage and administration instructions. Inform your healthcare provider of any pre-existing conditions or other medications you are taking. 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 closely monitors the safety of Sodium Chloride Tablet, and any new or severe adverse events should be reported to the FDA's MedWatch program.
The FDA has received approximately 143,107 adverse event reports associated with Sodium Chloride Tablet. 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 Chloride Tablet include Nausea, Myelosuppression, Dyspnoea, Off Label Use, Headache. By volume, the top reported reactions are: Nausea (4,885 reports), Myelosuppression (4,444 reports), Dyspnoea (4,211 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 Chloride Tablet.
Out of 67,828 classified reports, 54,842 (80.9%) were classified as serious and 12,986 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 Chloride Tablet break down by patient sex as follows: Female: 36,060, Male: 25,647, Unknown: 69. 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 Chloride Tablet adverse events are: age 54: 1,010 reports, age 65: 1,001 reports, age 67: 995 reports, age 68: 987 reports, age 71: 985 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 Chloride Tablet adverse event reports is Belleview Bioscience Llc. 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 Chloride Tablet include: Pyrexia, Fatigue, Vomiting, Diarrhoea, Pneumonia. 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 Chloride Tablet 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 Chloride Tablet has a safety concern score of 85 out of 100 (high 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. Severe reactions such as pneumonia, sepsis, and respiratory failure are common.
Key safety signals identified in Sodium Chloride Tablet's adverse event data include: High frequency of serious adverse events (54,842 out of 67,828, 80.9%). Frequent reports of respiratory issues like pneumonia and respiratory failure. Multiple blood-related issues including decreased white blood cell and platelet counts. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Sodium Chloride Tablet may interact with other medications, leading to adverse effects. It is important to consult a healthcare provider before use, especially in patients with pre-existing conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sodium Chloride Tablet.
Always follow the prescribed dosage and administration instructions. Inform your healthcare provider of any pre-existing conditions or other medications you are taking.
Sodium Chloride Tablet has 143,107 adverse event reports on file with the FDA. Significant drops in white blood cell count and platelet count are frequent. The volume of reports for Sodium Chloride Tablet reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors the safety of Sodium Chloride Tablet, and any new or severe adverse events should be reported to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with SODIUM CHLORIDE TABLET:
Drugs related to SODIUM CHLORIDE TABLET based on therapeutic use, drug class, or shared indications: