72/100 · Elevated
Manufactured by Jazz Pharmaceuticals, Inc.
Sodium Oxybate Adverse Events: High Serious Event Rate and Diverse Reactions
126,117 FDA adverse event reports analyzed
Last updated: 2026-05-12
SODIUM OXYBATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Jazz Pharmaceuticals, Inc.. Based on analysis of 126,117 FDA adverse event reports, SODIUM OXYBATE has a safety score of 72 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 OXYBATE include NAUSEA, ANXIETY, SOMNOLENCE, INSOMNIA, FEELING ABNORMAL. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SODIUM OXYBATE.
Sodium Oxybate has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 126,117 adverse event reports for this medication, which is primarily manufactured by Jazz Pharmaceuticals, Inc..
The most commonly reported adverse events include Nausea, Anxiety, Somnolence. Of classified reports, 49.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea and anxiety are the most common adverse events, with serious events comprising nearly 50% of reports.
A diverse range of reactions, including neurological and cardiovascular issues, are reported. Weight changes and sleep disorders are frequently reported, with some cases of weight decreased and increased. The drug is associated with a significant number of falls and hospitalizations, indicating potential safety risks. There are reports of drug ineffectiveness and intentional misuse, suggesting issues with product use and efficacy.
Patients taking Sodium Oxybate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Sodium oxybate is associated with a range of drug interactions, including potential effects on blood pressure and heart rate. Warnings include the risk of falls and accidents, particularly in elderly patients. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sodium Oxybate received a safety concern score of 72/100 (elevated concern). This is based on a 49.8% serious event ratio across 65,108 classified reports. The score accounts for 126,117 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: 45,733, Male: 17,889, Unknown: 16. The most frequently reported age groups are age 34 (662 reports), age 39 (659 reports), age 40 (655 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 65,108 classified reports for SODIUM OXYBATE:
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 oxybate is associated with a range of drug interactions, including potential effects on blood pressure and heart rate. Warnings include the risk of falls and accidents, particularly in elderly patients.
If you are taking Sodium Oxybate, here are important things to know. The most commonly reported side effects include nausea, anxiety, somnolence, insomnia, feeling abnormal. 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 unusual symptoms or side effects to their healthcare provider immediately. Follow prescribed dosing instructions carefully to minimize the risk of adverse events. 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 oxybate, and healthcare providers should be vigilant about potential serious adverse events and ensure proper patient education and monitoring.
The FDA has received approximately 126,117 adverse event reports associated with Sodium Oxybate. 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 Oxybate include Nausea, Anxiety, Somnolence, Insomnia, Feeling Abnormal. By volume, the top reported reactions are: Nausea (4,877 reports), Anxiety (3,934 reports), Somnolence (3,911 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 Oxybate.
Out of 65,108 classified reports, 32,402 (49.8%) were classified as serious and 32,706 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 Oxybate break down by patient sex as follows: Female: 45,733, Male: 17,889, Unknown: 16. 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 Oxybate adverse events are: age 34: 662 reports, age 39: 659 reports, age 40: 655 reports, age 44: 637 reports, age 30: 634 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 Oxybate adverse event reports is Jazz Pharmaceuticals, 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 Oxybate include: Headache, Fatigue, Depression, Dizziness, 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 Oxybate 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 Oxybate has a safety concern score of 72 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 anxiety are the most common adverse events, with serious events comprising nearly 50% of reports.
Key safety signals identified in Sodium Oxybate's adverse event data include: High rate of serious events (49.8%). Diverse range of reactions including neurological, cardiovascular, and gastrointestinal issues. Frequent reports of falls and hospitalizations. Significant number of reports related to drug ineffectiveness and intentional misuse. Common reactions such as nausea, anxiety, and somnolence. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Sodium oxybate is associated with a range of drug interactions, including potential effects on blood pressure and heart rate. Warnings include the risk of falls and accidents, particularly in elderly patients. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sodium Oxybate.
Patients should report any unusual symptoms or side effects to their healthcare provider immediately. Follow prescribed dosing instructions carefully to minimize the risk of adverse events.
Sodium Oxybate has 126,117 adverse event reports on file with the FDA. A diverse range of reactions, including neurological and cardiovascular issues, are reported. The volume of reports for Sodium Oxybate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of sodium oxybate, and healthcare providers should be vigilant about potential serious adverse events and ensure proper patient education and monitoring. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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