What the label lists and what reports show
Sodium oxybate side effects
Sodium oxybate's FDA label: “Most common adverse reactions in adults (≥5% and at least twice the incidence with placebo) were nausea, dizziness, vomiting, somnolence, enuresis, and tremor ( 6.1 ).” FAERS holds 61,996 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (4,292 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
- DEA Schedule III
Check it at the source: the sodium oxybate FDA label on DailyMed (effective July 1, 2025, Jazz Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of XYREM?XYREM can cause serious side effects, including: • See “What is the most important information I should know about XYREM?” • breathing problems, including: o slower breathing o trouble breathing o short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take XYREM. • mental health problems, including: o confusion o seeing or hearing things that are not real (hallucinations) o unusual or disturbing thoughts (abnormal thinking) o feeling anxious or upset o depression o thoughts of killing yourself or trying to kill yourself o increased tiredness o feelings of guilt or worthlessness o difficulty concentrating Call your doctor right away if you have or your child has symptoms of mental health problems, or a change in weight or appetite. • sleepwalking. […]
Source: FDA drug label, Jazz Pharmaceuticals, Inc., effective July 1, 2025 (SPL set 926eb076-a4a8-45e4-91ef-411f0aa4f3ca), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions in adults (≥5% and at least twice the incidence with placebo) were nausea, dizziness, vomiting, somnolence, enuresis, and tremor ( 6.1 ).
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reaction | Placebo (n=213) % | Xyrem 4.5g (n=185) % | Xyrem 6g (n=258) % | Xyrem 9g (n=178) % |
|---|---|---|---|---|
| ANY ADVERSE REACTION | 62 | 45 | 55 | 70 |
| Nausea | 3 | 8 | 13 | 20 |
| Vomiting | 1 | 2 | 4 | 11 |
| Diarrhea | 2 | 4 | 3 | 4 |
| Abdominal pain upper | 2 | 3 | 1 | 2 |
| Dry mouth | 2 | 1 | 2 | 1 |
| Pain | 1 | 1 | <1 | 3 |
| Feeling drunk | 1 | 0 | <1 | 3 |
| Edema peripheral | 1 | 3 | 0 | 0 |
| Cataplexy | 1 | 1 | 1 | 2 |
| Muscle spasms | 2 | 2 | <1 | 2 |
| Pain in extremity | 1 | 3 | 1 | 1 |
| Dizziness | 4 | 9 | 11 | 15 |
| Somnolence | 4 | 1 | 3 | 8 |
| Tremor | 0 | 0 | 2 | 5 |
| Disturbance in attention | 0 | 1 | 0 | 4 |
| Paresthesia | 1 | 2 | 1 | 3 |
| Sleep paralysis | 1 | 0 | 1 | 3 |
| Disorientation | 1 | 1 | 2 | 3 |
| Irritability | 1 | 0 | <1 | 3 |
| Sleepwalking | 0 | 0 | 0 | 3 |
| Anxiety | 1 | 1 | 1 | 2 |
| Enuresis | 1 | 3 | 3 | 7 |
| Hyperhidrosis | 0 | 1 | 1 | 3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions appear in other sections of the labeling: • CNS depression [see Warnings and Precautions ( 5.1 )] • Abuse and Misuse [see Warnings and Precautions ( 5.2 )] • Respiratory Depression and Sleep-Disordered Breathing [see Warnings and Precautions ( 5.4 )] • Depression and Suicidality [see Warnings and Precautions ( 5.5 )] • Other Behavioral or Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Parasomnias [see Warnings and Precautions ( 5.7 )] • Use in Patients Sensitive to High Sodium Intake [see Warnings and Precautions ( 5.8 )] Most common adverse reactions in adults (≥5% and at least twice the incidence with placebo) were nausea, dizziness, vomiting, somnolence, enuresis, and tremor ( 6.1 ). Most common adverse reactions in pediatric patients (≥5%) were nausea, enuresis, vomiting, headache, weight decreased, decreased appetite, dizziness, and sleepwalking ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals, Inc. at 1-800-520-5568, or FDA at 1-800-FDA-1088 or www.fda.gov/Medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Source: FDA drug label, Jazz Pharmaceuticals, Inc., effective July 1, 2025 (SPL set 926eb076-a4a8-45e4-91ef-411f0aa4f3ca), via openFDA; the full label on DailyMed
What do FAERS reports show?
61,996 reports list sodium oxybate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 935 are coded as a death and 7,490 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (19,535, against a median of 2,958 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Sodium oxybate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions