Oxybate side effects: what 61,996 FDA adverse event reports show
Drug class
Central nervous system depressant
Label matched
Sodium Oxybate (Sodium Oxybate)
Who reports
61,996 reports · 52% serious · 935 with death outcome · 72% female
Used for
Sodium Oxybate Oral Solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Sodium Oxybate Oral Solution is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1 ).
What it is
Sodium oxybate, a CNS depressant, is the active ingredient in Sodium Oxybate Oral Solution.
Boxed warning
CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE. • Central Nervous System Depression Sodium Oxybate Oral Solution is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with Sodium Oxybate Oral Solution [see Warnings and Precautions ( 5.1 )].
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,135 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Cataplexy | 928 | 606.0 543.0–676.3ROR 614.7 · calibrated p 7e-15 ✓ | 206.9 EB05 196.0 · IC025 +7.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=694 | not reported in cached trials |
| Pre-existing condition improved | 2,218 | 174.1 165.4–183.3ROR 180.2 · calibrated p 1e-9 ✓ | 112.3 EB05 108.5 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=1,112 | not reported in cached trials |
| Parasomnia | 210 | 137.1 116.6–161.2ROR 137.6 · calibrated p 1e-8 ✓ | 95.0 EB05 84.7 · IC025 +6.1 3/3 methods agree | Labeled — boxed warning exact term | serious n=87 | not reported in cached trials |
| Sleep-related eating disorder | 258 | 121.4 105.2–140.1ROR 121.9 · calibrated p 3e-8 ✓ | 87.3 EB05 78.7 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=112 | not reported in cached trials |
| Sleep inertia | 23 | 106.5 66.4–170.8ROR 106.5 · calibrated p 3e-7 ✓ | 75.0 EB05 52.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Hypnagogic hallucination | 69 | 94.4 72.2–123.6ROR 94.5 · calibrated p 3e-7 ✓ | 71.5 EB05 58.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=42 | not reported in cached trials |
| Abnormal sleep-related event | 283 | 86.9 76.2–99.1ROR 87.3 · calibrated p 3e-7 ✓ | 68.0 EB05 61.6 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious n=111 | not reported in cached trials |
| Sleep paralysis | 301 | 82.8 73.0–94.0ROR 83.2 · calibrated p 5e-7 ✓ | 65.5 EB05 59.5 · IC025 +5.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=138 | not reported in cached trials |
| Enuresis | 803 | 79.4 73.5–85.7ROR 80.4 · calibrated p 6e-7 ✓ | 63.5 EB05 59.9 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=303 | not reported in cached trials |
| Periodic limb movement disorder | 71 | 76.3 58.9–98.8ROR 76.4 · calibrated p 1e-6 ✓ | 60.6 EB05 49.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=51 | not reported in cached trials |
| Asthma exercise induced | 65 | 73.6 56.2–96.4ROR 73.7 · calibrated p 2e-6 ✓ | 58.9 EB05 47.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=48 | not reported in cached trials |
| Terminal insomnia | 323 | 73.1 64.8–82.5ROR 73.5 · calibrated p 1e-6 ✓ | 59.3 EB05 54.1 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Product administration interrupted | 1,315 | 66.2 62.4–70.2ROR 67.5 · calibrated p 2e-6 ✓ | 54.8 EB05 52.4 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious n=1,148 | not reported in cached trials |
| Confusional arousal | 27 | 65.4 43.2–98.9ROR 65.4 · calibrated p 6e-6 ✓ | 52.4 EB05 37.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Somnambulism | 1,083 | 62.9 58.9–67.1ROR 63.9 · calibrated p 3e-6 ✓ | 52.5 EB05 50.0 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=552 | not reported in cached trials |
| Narcolepsy | 287 | 57.4 50.6–65.0ROR 57.6 · calibrated p 6e-6 ✓ | 48.5 EB05 44.0 · IC025 +5.3 3/3 methods agree | Labeled — boxed warning exact term | serious n=248 | not reported in cached trials |
| Snoring | 573 | 57.2 52.4–62.5ROR 57.7 · calibrated p 6e-6 ✓ | 48.5 EB05 45.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=276 | not reported in cached trials |
| Sleep attacks | 70 | 55.4 42.9–71.4ROR 55.4 · calibrated p 1e-5 ✓ | 46.7 EB05 38.2 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Central sleep apnoea syndrome | 45 | 52.5 38.3–71.9ROR 52.5 · calibrated p 2e-5 ✓ | 44.3 EB05 34.5 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=31 | not reported in cached trials |
| Perinatal depression | 62 | 51.6 39.5–67.5ROR 51.7 · calibrated p 2e-5 ✓ | 43.9 EB05 35.5 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=60 · ♀ 100% (drug 72%) | not reported in cached trials |
| Sleep apnoea syndrome | 2,581 | 49.9 47.9–51.9ROR 51.9 · calibrated p 1e-5 ✓ | 43.2 EB05 41.8 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 56.3 | not reported in cached trials |
| Therapeutic product effect prolonged | 57 | 46.6 35.3–61.5ROR 46.6 · calibrated p 3e-5 ✓ | 40.2 EB05 32.2 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 176 | 46.1 39.4–54.0ROR 46.2 · calibrated p 2e-5 ✓ | 40.2 EB05 35.4 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=166 | not reported in cached trials |
| Hangover | 391 | 39.7 35.7–44.1ROR 39.9 · calibrated p 5e-5 ✓ | 35.3 EB05 32.5 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=148 | not reported in cached trials |
| Sleep talking | 185 | 38.8 33.3–45.2ROR 38.9 · calibrated p 7e-5 ✓ | 34.5 EB05 30.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=61 | not reported in cached trials |
| Postural orthostatic tachycardia syndrome | 128 | 34.6 28.8–41.5ROR 34.6 · calibrated p 1e-4 ✓ | 31.1 EB05 26.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=98 | not reported in cached trials |
| Ehlers-danlos syndrome | 45 | 34.4 25.3–46.8ROR 34.4 · calibrated p 2e-4 ✓ | 30.7 EB05 23.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 100% (drug 72%) · 71% consumer | not reported in cached trials |
| Substance use | 140 | 31.9 26.8–38.0ROR 32.0 · calibrated p 2e-4 ✓ | 29.0 EB05 25.2 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=84 | not reported in cached trials |
| Initial insomnia | 917 | 31.6 29.5–33.8ROR 32.0 · calibrated p 2e-4 ✓ | 28.8 EB05 27.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=195 | not reported in cached trials |
| Seasonal affective disorder | 28 | 30.6 20.8–45.1ROR 30.6 · calibrated p 4e-4 ✓ | 27.5 EB05 20.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Moaning | 97 | 30.3 24.6–37.3ROR 30.3 · calibrated p 3e-4 ✓ | 27.6 EB05 23.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=34 | not reported in cached trials |
| Victim of abuse | 23 | 29.7 19.3–45.5ROR 29.7 · calibrated p 5e-4 ✓ | 26.7 EB05 18.7 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=22 · ♀ 100% (drug 72%) | not reported in cached trials |
| Nasal septal operation | 30 | 29.5 20.3–42.9ROR 29.5 · calibrated p 4e-4 ✓ | 26.7 EB05 19.6 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=27 | not reported in cached trials |
| Victim of sexual abuse | 43 | 28.9 21.2–39.5ROR 28.9 · calibrated p 4e-4 ✓ | 26.3 EB05 20.3 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=43 · ♀ 100% (drug 72%) | not reported in cached trials |
| Sudden onset of sleep | 105 | 26.0 21.3–31.7ROR 26.1 · calibrated p 6e-4 ✓ | 24.0 EB05 20.4 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=58 | not reported in cached trials |
| Feeling drunk | 543 | 25.1 23.0–27.3ROR 25.3 · calibrated p 7e-4 ✓ | 23.3 EB05 21.7 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=181 | not reported in cached trials |
| Post concussion syndrome | 24 | 24.3 16.0–36.8ROR 24.3 · calibrated p 0.001 ✓ | 22.3 EB05 15.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Rapid eye movement sleep behaviour disorder | 26 | 22.2 14.9–33.1ROR 22.2 · calibrated p 0.002 ✓ | 20.5 EB05 14.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Wisdom teeth removal | 84 | 22.1 17.7–27.5ROR 22.1 · calibrated p 0.001 ✓ | 20.6 EB05 17.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=28 | not reported in cached trials |
| Rapid eye movements sleep abnormal | 26 | 20.8 14.0–30.9ROR 20.8 · calibrated p 0.002 ✓ | 19.3 EB05 13.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Oxybate as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00423813 — A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia. (N=573, PHASE3; 59 AE terms posted; arms: Placebo; Xyrem (Sodium Oxybate) 4.5g; Xyrem (Sodium Oxybate) 6.0g)
- NCT00423605 — Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia. (N=560, PHASE3; 64 AE terms posted; arms: Xyrem 4.5 g to 9.0 g)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nausea | 4,928 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.991 | 2.0 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00423813: 40/189 (21.2%) on Oxybate; 16/188 (8.5%) control |
| Anxiety | 3,979 | 4.5 4.4–4.7ROR 4.7 · calibrated p 0.265 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.2 | NCT00423813: 15/189 (7.9%) on Oxybate; 3/188 (1.6%) control |
| Somnolence (drowsiness) | 3,965 | 6.4 6.2–6.6ROR 6.8 · calibrated p 0.108 | 6.3 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | NCT00423813: 11/189 (5.8%) on Oxybate; 3/188 (1.6%) control |
| Insomnia (trouble sleeping) | 3,371 | 4.1 3.9–4.2ROR 4.3 · calibrated p 0.334 | 4.0 EB05 3.9 · IC025 +2.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 2.8 | NCT00423813: 8/189 (4.2%) on Oxybate; 6/188 (3.2%) control |
| Feeling abnormal | 3,223 | 4.3 4.2–4.5ROR 4.5 · calibrated p 0.296 | 4.3 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 | not reported in cached trials |
| Fatigue (tiredness) | 3,214 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.536 | 1.3 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.1 | NCT00423813: 11/189 (5.8%) on Oxybate; 4/188 (2.1%) control |
| Headache | 3,205 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.753 | 1.6 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00423813: 1/189 (0.5%) on Oxybate (serious AE) |
| Depression | 3,171 | 4.5 4.3–4.6ROR 4.7 · calibrated p 0.274 | 4.4 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.4 | NCT00423813: 5/189 (2.6%) on Oxybate |
| Dizziness | 2,969 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.920 | 1.9 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT00423813: 25/189 (13.2%) on Oxybate; 3/188 (1.6%) control |
| Weight decreased (weight loss) | 2,892 | 3.3 3.2–3.5ROR 3.4 · calibrated p 0.497 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | NCT00423813: 3/189 (1.6%) on Oxybate; 1/188 (0.5%) control |
| Condition aggravated | 2,803 | 3.0 2.9–3.1ROR 3.1 · calibrated p 0.602 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | not reported in cached trials |
| Drug ineffective (drug did not work) | 2,639 | 0.6 0.6–0.7ROR 0.6 · calibrated p 0.095 | 0.6 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Fall | 2,601 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.781 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | NCT00423605: 20/560 (3.6%) on Oxybate |
| Sleep apnoea syndrome | 2,581 | 49.9 47.9–51.9ROR 51.9 · calibrated p 1e-5 ✓ | 43.2 EB05 41.8 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 56.3 | not reported in cached trials |
| Unevaluable event | 2,382 | 10.4 10.0–10.8ROR 10.7 · calibrated p 0.025 ✓ | 10.1 EB05 9.7 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Pre-existing condition improved — n=2,218, PRR 174.1
- Sleep-related eating disorder — n=258, PRR 121.4
- Sleep inertia — n=23, PRR 106.5
- Hypnagogic hallucination — n=69, PRR 94.4
- Periodic limb movement disorder — n=71, PRR 76.3
- Asthma exercise induced — n=65, PRR 73.6
- Terminal insomnia — n=323, PRR 73.1
- Confusional arousal — n=27, PRR 65.4
- Snoring — n=573, PRR 57.2
- Sleep attacks — n=70, PRR 55.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Methotrexate Sodium ↔ Rheumatoid Arthritis.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Oxybate?
In FDA FAERS, the most frequently co-reported reaction terms for Oxybate are nausea, anxiety, somnolence, insomnia, feeling abnormal, fatigue. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Oxybate have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE. • Central Nervous System Depression Sodium Oxybate Oral Solution is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with Sodium Oxybate Oral Solution [see Warnings and Precautions ( 5.1 )].
Do FAERS signals prove that Oxybate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID bcef2c95-35e9-464d-9025-652acff769e7, effective 20230425; matched on
openfda.generic_name.exact:"SODIUM OXYBATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,175 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
OXYBATE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.