65/100 · Elevated
Manufactured by Huizhou Jinsheng Medical Technology Co., Ltd
Moderate Safety Concerns with Sodium Chloride Use
152,527 FDA adverse event reports analyzed
Last updated: 2026-05-12
SODIUM CHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Huizhou Jinsheng Medical Technology Co., Ltd. Based on analysis of 152,527 FDA adverse event reports, SODIUM CHLORIDE 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 CHLORIDE include NAUSEA, DYSPNOEA, OFF LABEL USE, MYELOSUPPRESSION, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SODIUM CHLORIDE.
Sodium Chloride 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 152,527 adverse event reports for this medication, which is primarily manufactured by Huizhou Jinsheng Medical Technology Co., Ltd.
The most commonly reported adverse events include Nausea, Dyspnoea, Off Label Use. Of classified reports, 80.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea and dyspnea are the most frequently reported adverse reactions.
Serious adverse events, such as pneumonia and sepsis, are common. There is a high volume of reports related to drug use issues and dosing errors.
Patients taking Sodium Chloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions and improper dosing are common issues, and patients should be monitored closely for signs of serious adverse events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sodium Chloride received a safety concern score of 65/100 (elevated concern). This is based on a 80.2% serious event ratio across 72,836 classified reports. The score accounts for 152,527 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: 38,853, Male: 27,386, Unknown: 74. The most frequently reported age groups are age 65 (1,080 reports), age 67 (1,072 reports), age 68 (1,066 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 72,836 classified reports for SODIUM CHLORIDE:
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.
Drug interactions and improper dosing are common issues, and patients should be monitored closely for signs of serious adverse events.
If you are taking Sodium Chloride, here are important things to know. The most commonly reported side effects include nausea, dyspnoea, off label use, myelosuppression, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Ensure proper dosing and administration under medical supervision to avoid serious complications. Report any adverse reactions to the FDA for further evaluation. 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.
Regulatory oversight is ongoing, with a focus on ensuring proper use and dosing to minimize adverse events.
The FDA has received approximately 152,527 adverse event reports associated with Sodium Chloride. 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 include Nausea, Dyspnoea, Off Label Use, Myelosuppression, Headache. By volume, the top reported reactions are: Nausea (5,237 reports), Dyspnoea (4,544 reports), Off Label Use (4,540 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.
Out of 72,836 classified reports, 58,417 (80.2%) were classified as serious and 14,419 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 break down by patient sex as follows: Female: 38,853, Male: 27,386, Unknown: 74. 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 adverse events are: age 65: 1,080 reports, age 67: 1,072 reports, age 68: 1,066 reports, age 70: 1,065 reports, age 54: 1,063 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 adverse event reports is Huizhou Jinsheng Medical Technology Co., Ltd. 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 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 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 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. Nausea and dyspnea are the most frequently reported adverse reactions.
Key safety signals identified in Sodium Chloride's adverse event data include: High frequency of serious adverse events (58,417 out of 72,836, 80.2%). Diverse range of reactions, including respiratory, gastrointestinal, and hematological issues. Significant number of reports related to improper drug use and dosing. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions and improper dosing are common issues, and patients should be monitored closely for signs of serious adverse events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sodium Chloride.
Ensure proper dosing and administration under medical supervision to avoid serious complications. Report any adverse reactions to the FDA for further evaluation.
Sodium Chloride has 152,527 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and sepsis, are common. The volume of reports for Sodium Chloride reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on ensuring proper use and dosing to minimize adverse events. 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:
Drugs related to SODIUM CHLORIDE based on therapeutic use, drug class, or shared indications: