Drugs › Central nervous system depressant
Generic name
Sodium oxybate: adverse event reports filed with FDA
1,185 reports list it as a suspect or interacting product, 2004–2026. Class: Central nervous system depressant.
- 1,185
- reports as suspect product
- 0% of all reports · about 53 a year
- 244
- reports, 12 months to June 2026
- 336 in the 12 months before
- 88.5%
- marked serious by the reporter
- 54.4% across the class
- 9.1%
- record death among outcomes, as reported
- 108 reports · not verified by FDA
Between March 2004 and June 2026, 1,185 adverse event reports received by FDA list sodium oxybate, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (65) are left out of every figure here.
In the 12 months to June 2026, 244 reports listed it, down 27% from 336 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 53 reports a year and 0% of the 20,646,523 reports in the database, and 1.6% of the reports for the central nervous system depressant class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded product administration interrupted (13.2%), surgery (12.7%) and off label use (7.3%). A report can list several reactions, so shares add to more than 100%; 393 different terms appear across these reports. Product administration interrupted is recorded in 13.2% of these reports, a larger share than in the median central nervous system depressant drug (8%).
88.5% of the reports are marked serious by the reporter (54.4% across the class); 9.1% record death among the outcomes and 24.7% record hospitalisation, as reported. 54.2% of the reports came from consumers, and the largest patient age group is 18 to 44 (29.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Sodium oxybate reports recording the termmedian drug in central nervous system depressant
- Surgeryan operation12.7%150
- Off label useused for a purpose or in a way not on the label7.3%86
- Product dose omission issuea dose was missed5.7%68
- Toxicity to various agentspoisoning or toxic effect of one or more substances5.6%66
- Falla fall4.9%58
- Hospitalisationadmission to hospital4.9%58
- Drug interactionan interaction between medicines4.8%57
- Overdosea dose above the recommended amount4.8%57
- Drug ineffectivethe medicine did not work as expected4.6%55
- Nauseafeeling sick4.6%54
- Somnolencedrowsiness4.5%53
- Drug abusemisuse of a medicine4.3%51
- Anxietyanxiety4.2%50
- Suicidal ideationthoughts of suicide3.8%45
- Depressionlow mood3.7%44
- Deaththe patient died; cause not stated by this term3.5%42
- Intentional product use issuedeliberate use not as intended3.2%38
- Dizzinesslight-headedness or unsteadiness3.1%37
- Nephrolithiasiskidney stones3%35
- Weight decreasedweight loss2.9%34
- Hypertensionhigh blood pressure2.7%32
- Vomitingbeing sick2.7%32
- Headachehead pain2.6%31
- Drug hypersensitivityan allergic-type reaction to a medicine2.4%29
- Feeling abnormalfeeling odd or not right2.3%27
- Fatiguetiredness2.2%26
- Illness2.2%26
- Intentional product misusedeliberate use not as intended2%24
Top 30 of 393 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the central nervous system depressant class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 74,407 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 83% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Narcolepsy | 840 | 70.9% |
| Hypersomnia | 37 | 3.1% |
| Cataplexy | 17 | 1.4% |
| Substance abuse | 10 | 0.8% |
| Drug abuse | 7 | 0.6% |
| Fibromyalgia | 4 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,185 reports.
In context
| Measure | Sodium oxybate | Central nervous system depressant | All reports |
|---|---|---|---|
| Reports as suspect product | 1,185 | 74,407 | 20,646,523 |
| Share of that pool | — | 1.6% | 0% |
| Reports, latest 12 months | 244 | — | 1,332,454 |
| Marked serious | 88.5% | 54.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 91 | 14 | 91 |
| Hospitalisation recorded, per 1,000 reports | 247 | 129 | 213 |
| Consumer-filed share | 54.2% | 36.8% | 45.8% |
| Top term, share of reports | Product administration interrupted 13.2% | median 8% | 0% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the central nervous system depressant class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Xyrem | brand | 61,308 | 218 | 52.1% |
| Xywav | brand | 8,426 | 1,317 | 82.7% |
| Lumryz | brand | 3,488 | 325 | 13.7% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Sodium oxybate reports
How many adverse event reports has FDA received for Sodium oxybate?
1,185 reports list Sodium oxybate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 244 of them arrived in the latest 12 months. Another 65 list it only as a concomitant medication.
What reactions are recorded in Sodium oxybate reports?
product administration interrupted (13.2%), surgery (12.7%), off label use (7.3%), product dose omission issue (5.7%) and toxicity to various agents (5.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Sodium oxybate was responsible.
How serious are the reports?
88.5% are marked serious by the reporter. Among the outcomes recorded, 9.1% of reports include death and 24.7% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (54.2%), other health professional (23.7%) and physician (19%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Sodium oxybate rising?
244 reports in the 12 months to June 2026, down 27% from 336 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Sodium oxybate was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Sodium oxybate?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Sodium oxybate as a suspect or interacting product; reports listing it only as a concomitant medication (65) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.