85/100 · Critical
Manufactured by Kesin Pharma Corporation
High Safety Concerns with Sodium Chloride Tablets
143,106 FDA adverse event reports analyzed
Last updated: 2026-05-12
SODIUM CHLORIDE TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kesin Pharma Corporation. Based on analysis of 143,106 FDA adverse event reports, SODIUM CHLORIDE TABLETS 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 TABLETS 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 TABLETS.
Sodium Chloride Tablets 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 143,106 adverse event reports for this medication, which is primarily manufactured by Kesin Pharma Corporation.
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 drug interactions and warnings are present, especially for elderly patients. Regulatory oversight is necessary given the high volume of adverse reports.
Patients taking Sodium Chloride Tablets should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Sodium Chloride Tablets can cause severe reactions such as pneumonia, sepsis, and respiratory failure. Warnings are particularly important for elderly patients and those with pre-existing conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sodium Chloride Tablets received a safety concern score of 85/100 (high concern). This is based on a 80.9% serious event ratio across 67,832 classified reports. The score accounts for 143,106 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: 36,061, Male: 25,650, Unknown: 69. The most frequently reported age groups are age 54 (1,010 reports), age 65 (1,000 reports), age 67 (995 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 67,832 classified reports for SODIUM CHLORIDE TABLETS:
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 Tablets can cause severe reactions such as pneumonia, sepsis, and respiratory failure. Warnings are particularly important for elderly patients and those with pre-existing conditions.
If you are taking Sodium Chloride Tablets, 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. Patients should report any severe symptoms to their healthcare provider immediately. Follow prescribed dosing instructions and do not use the product for unapproved indications. 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 should closely monitor the safety of Sodium Chloride Tablets, especially in elderly and immunocompromised patients. Healthcare providers should be vigilant about potential serious adverse events and ensure proper use.
The FDA has received approximately 143,106 adverse event reports associated with Sodium Chloride Tablets. 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 Tablets 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 Tablets.
Out of 67,832 classified reports, 54,845 (80.9%) were classified as serious and 12,987 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 Tablets break down by patient sex as follows: Female: 36,061, Male: 25,650, 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 Tablets adverse events are: age 54: 1,010 reports, age 65: 1,000 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 Tablets adverse event reports is Kesin Pharma Corporation. 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 Tablets 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 Tablets 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 Tablets 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 Tablets's adverse event data include: High frequency of serious reactions (54,845 out of 67,832, 80.9%). Multiple blood count abnormalities (white blood cell, platelet, and neutrophil decreases). Common reactions include pneumonia, sepsis, and respiratory failure. Significant number of reports involving drug ineffectiveness and inappropriate use. Elderly patients (ages 65-73) are disproportionately affected. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Sodium Chloride Tablets can cause severe reactions such as pneumonia, sepsis, and respiratory failure. Warnings are particularly important for elderly patients and those 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 Tablets.
Patients should report any severe symptoms to their healthcare provider immediately. Follow prescribed dosing instructions and do not use the product for unapproved indications.
Sodium Chloride Tablets has 143,106 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 Tablets reflects both the drug's usage level and the vigilance of the reporting community.
The FDA should closely monitor the safety of Sodium Chloride Tablets, especially in elderly and immunocompromised patients. Healthcare providers should be vigilant about potential serious adverse events and ensure proper use. 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 TABLETS:
Drugs related to SODIUM CHLORIDE TABLETS based on therapeutic use, drug class, or shared indications: