Drug · FAERS side-effect profile with label screen
Oxybates side effects: what 8,557 FDA adverse event reports show
Drug class
No validated FDA label found
closest label found was a multi-ingredient product (Calcium, Magnesium, Potassium, And Sodium Oxybates) and was not used
Who reports
8,557 reports · 82% serious · 81 with death outcome · 73% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Reporting / coding artifact 9No label text to screen 31
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 966 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Sleep inertia | 19 | 637.5 384.7–1,056.4ROR 638.9 · χ² 9,056 / p <1e-300 | 334.5 EB05 226.3 · IC025 +4.4 3/3 methods agree | No label text to screen | serious n=16 | no trial data cached |
| Product administration interrupted | 1,528 | 610.9 580.0–643.5ROR 743.4 · χ² 742,445 / p <1e-300 | 484.9 EB05 464.8 · IC025 +8.6 3/3 methods agree | Reporting / coding artifact | serious n=1,467 | no trial data cached |
| Central sleep apnoea syndrome | 28 | 235.7 160.0–347.2ROR 236.5 · χ² 5,750 / p <1e-300 | 187.5 EB05 136.2 · IC025 +4.9 3/3 methods agree | No label text to screen | serious n=22 | no trial data cached |
| Polycystic ovarian syndrome | 22 | 155.9 101.3–239.7ROR 156.3 · χ² 3,036 / p <1e-300 | 130.2 EB05 90.6 · IC025 +4.4 3/3 methods agree | No label text to screen | serious n=22 · ♀ 100% (drug 73%) | no trial data cached |
| Periodic limb movement disorder | 20 | 140.5 89.5–220.3ROR 140.8 · χ² 2,487 / p <1e-300 | 118.1 EB05 80.7 · IC025 +4.2 3/3 methods agree | No label text to screen | serious n=19 | no trial data cached |
| Parasomnia | 38 | 140.4 101.3–194.5ROR 141.0 · χ² 4,839 / p <1e-300 | 124.5 EB05 94.7 · IC025 +5.1 3/3 methods agree | No label text to screen | serious n=25 | no trial data cached |
| Postural orthostatic tachycardia syndrome | 64 | 125.7 97.9–161.5ROR 126.6 · χ² 7,408 / p <1e-300 | 115.5 EB05 93.6 · IC025 +5.5 3/3 methods agree | No label text to screen | serious n=64 · ♀ 95% (drug 73%) | no trial data cached |
| Obstructive sleep apnoea syndrome | 63 | 115.7 90.0–148.9ROR 116.6 · χ² 6,730 / p <1e-300 | 107.0 EB05 86.6 · IC025 +5.5 3/3 methods agree | No label text to screen | serious n=58 | no trial data cached |
| Sleep-related eating disorder | 42 | 114.6 84.2–156.1ROR 115.2 · χ² 4,410 / p <1e-300 | 104.4 EB05 80.5 · IC025 +5.1 3/3 methods agree | No label text to screen | serious n=26 | no trial data cached |
| Cataplexy | 60 | 107.4 83.0–138.9ROR 108.1 · χ² 5,953 / p <1e-300 | 99.7 EB05 80.2 · IC025 +5.4 3/3 methods agree | No label text to screen | serious n=59 | no trial data cached |
| Enuresis | 159 | 100.3 85.7–117.4ROR 102.2 · χ² 14,922 / p <1e-300 | 95.3 EB05 83.5 · IC025 +6.0 3/3 methods agree | No label text to screen | serious n=120 | no trial data cached |
| Perinatal depression | 14 | 79.4 46.6–135.1ROR 79.5 · χ² 975 / p 3e-214 | 69.9 EB05 44.2 · IC025 +3.5 3/3 methods agree | No label text to screen | serious n=14 | no trial data cached |
| Pre-existing condition improved | 191 | 76.4 66.3–88.1ROR 78.2 · χ² 13,714 / p <1e-300 | 73.6 EB05 65.2 · IC025 +5.7 3/3 methods agree | No label text to screen | serious n=175 | no trial data cached |
| Sleep paralysis | 44 | 75.9 56.2–102.3ROR 76.3 · χ² 3,080 / p <1e-300 | 71.4 EB05 55.4 · IC025 +4.8 3/3 methods agree | No label text to screen | serious n=35 | no trial data cached |
| Asthma exercise induced | 10 | 72.5 38.7–136.0ROR 72.6 · χ² 617 / p 1e-136 | 62.5 EB05 36.3 · IC025 +3.0 3/3 methods agree | No label text to screen | serious n=9 | no trial data cached |
| Medical procedure | 46 | 70.7 52.8–94.8ROR 71.1 · χ² 3,005 / p <1e-300 | 66.9 EB05 52.2 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=46 · 76% consumer | no trial data cached |
| Mast cell activation syndrome | 36 | 68.4 49.2–95.2ROR 68.7 · χ² 2,261 / p <1e-300 | 64.4 EB05 48.6 · IC025 +4.6 3/3 methods agree | No label text to screen | serious n=36 · 81% consumer | no trial data cached |
| Suspected suicide attempt | 15 | 66.5 39.8–111.0ROR 66.6 · χ² 879 / p 2e-193 | 60.0 EB05 38.6 · IC025 +3.5 3/3 methods agree | No label text to screen | serious n=15 | no trial data cached |
| Narcolepsy | 49 | 65.3 49.2–86.6ROR 65.7 · χ² 2,958 / p <1e-300 | 62.1 EB05 48.9 · IC025 +4.8 3/3 methods agree | No label text to screen | serious n=49 | no trial data cached |
| Therapeutic procedure | 35 | 64.1 45.8–89.5ROR 64.3 · χ² 2,055 / p <1e-300 | 60.5 EB05 45.5 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=33 · 80% consumer | no trial data cached |
| Temporomandibular pain and dysfunction syndrome | 10 | 63.9 34.1–119.7ROR 64.0 · χ² 544 / p 2e-120 | 56.0 EB05 32.5 · IC025 +2.9 3/3 methods agree | No label text to screen | serious n=10 | no trial data cached |
| Therapeutic product effect prolonged | 11 | 61.7 33.9–112.1ROR 61.7 · χ² 582 / p 6e-129 | 54.8 EB05 32.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=11 | no trial data cached |
| Somnambulism | 154 | 58.6 50.0–68.7ROR 59.7 · χ² 8,459 / p <1e-300 | 56.9 EB05 49.7 · IC025 +5.3 3/3 methods agree | No label text to screen | serious n=120 | no trial data cached |
| Snoring | 88 | 58.5 47.4–72.2ROR 59.1 · χ² 4,798 / p <1e-300 | 56.4 EB05 47.2 · IC025 +5.1 3/3 methods agree | No label text to screen | serious n=78 | no trial data cached |
| Wrong dose | 54 | 55.8 42.6–73.0ROR 56.1 · χ² 2,786 / p <1e-300 | 53.6 EB05 42.6 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious n=48 | no trial data cached |
| Surgery | 1,238 | 53.4 50.7–56.3ROR 62.3 · χ² 62,453 / p <1e-300 | 52.3 EB05 49.9 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 42.0 · 74% consumer | no trial data cached |
| Intentional dose omission | 574 | 52.5 48.5–56.9ROR 56.2 · χ² 28,366 / p <1e-300 | 51.3 EB05 47.9 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 69.9 | no trial data cached |
| Hangover | 67 | 47.3 37.1–60.1ROR 47.6 · χ² 2,931 / p <1e-300 | 45.8 EB05 37.3 · IC025 +4.7 3/3 methods agree | No label text to screen | serious n=57 | no trial data cached |
| Abnormal sleep-related event | 25 | 47.1 31.7–69.9ROR 47.2 · χ² 1,061 / p 5e-233 | 44.7 EB05 31.9 · IC025 +3.9 3/3 methods agree | No label text to screen | serious n=21 | no trial data cached |
| Substance use | 29 | 47.0 32.5–67.8ROR 47.1 · χ² 1,235 / p 8e-271 | 44.8 EB05 32.7 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=26 | no trial data cached |
| Drug titration error | 46 | 44.3 33.1–59.3ROR 44.5 · χ² 1,870 / p <1e-300 | 42.8 EB05 33.4 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=41 | no trial data cached |
| Post-acute covid-19 syndrome | 20 | 40.3 25.9–62.6ROR 40.4 · χ² 715 / p 8e-158 | 38.3 EB05 26.2 · IC025 +3.6 3/3 methods agree | No label text to screen | serious n=20 | no trial data cached |
| Feeling drunk | 118 | 39.3 32.8–47.1ROR 39.9 · χ² 4,303 / p <1e-300 | 38.5 EB05 33.0 · IC025 +4.8 3/3 methods agree | No label text to screen | serious n=108 | no trial data cached |
| Essential tremor | 16 | 35.6 21.7–58.3ROR 35.7 · χ² 497 / p 3e-110 | 33.8 EB05 22.1 · IC025 +3.3 3/3 methods agree | No label text to screen | serious n=15 | no trial data cached |
| Craniofacial fracture | 11 | 33.8 18.6–61.2ROR 33.8 · χ² 313 / p 2e-70 | 31.6 EB05 18.8 · IC025 +2.8 3/3 methods agree | No label text to screen | serious n=11 | no trial data cached |
| Sleep deficit | 28 | 33.7 23.2–48.8ROR 33.8 · χ² 843 / p 1e-185 | 32.5 EB05 23.6 · IC025 +3.8 3/3 methods agree | No label text to screen | serious n=24 | no trial data cached |
| Metabolic surgery | 15 | 33.3 20.0–55.4ROR 33.4 · χ² 432 / p 3e-96 | 31.7 EB05 20.4 · IC025 +3.1 3/3 methods agree | No label text to screen | serious n=13 | no trial data cached |
| Mycotic allergy | 11 | 32.4 17.9–58.7ROR 32.4 · χ² 300 / p 2e-67 | 30.4 EB05 18.0 · IC025 +2.7 3/3 methods agree | No label text to screen | serious n=11 | no trial data cached |
| Sleep talking | 22 | 31.9 21.0–48.6ROR 32.0 · χ² 621 / p 3e-137 | 30.8 EB05 21.4 · IC025 +3.5 3/3 methods agree | No label text to screen | serious n=18 | no trial data cached |
| Attention deficit hyperactivity disorder | 53 | 31.7 –ROR 31.8 · χ² – | – | No label text to screen | serious n=51 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Product administration interrupted | 1,528 | 610.9 580.0–643.5ROR 743.4 · χ² 742,445 / p <1e-300 | 484.9 EB05 464.8 · IC025 +8.6 3/3 methods agree | Reporting / coding artifact | serious n=1,467 | no trial data cached |
| Surgery | 1,238 | 53.4 50.7–56.3ROR 62.3 · χ² 62,453 / p <1e-300 | 52.3 EB05 49.9 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 42.0 · 74% consumer | no trial data cached |
| Nausea | 924 | 2.9 2.7–3.1ROR 3.1 · χ² 1,167 / p 4e-256 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen | serious PRR 3.3 | no trial data cached |
| Product dose omission issue | 851 | 7.3 6.9–7.8ROR 8.0 · χ² 4,703 / p <1e-300 | 7.3 EB05 6.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 18.0 | no trial data cached |
| Anxiety | 663 | 5.7 5.3–6.1ROR 6.1 · χ² 2,596 / p <1e-300 | 5.7 EB05 5.3 · IC025 +2.4 3/3 methods agree | No label text to screen | serious PRR 4.9 | no trial data cached |
| Intentional dose omission | 574 | 52.5 48.5–56.9ROR 56.2 · χ² 28,366 / p <1e-300 | 51.3 EB05 47.9 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 69.9 | no trial data cached |
| Dizziness | 512 | 2.5 2.3–2.7ROR 2.6 · χ² 479 / p 2e-106 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen | serious PRR 2.8 | no trial data cached |
| Headache | 511 | 2.0 1.8–2.2ROR 2.1 · χ² 262 / p 3e-59 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen | serious PRR 2.5 | no trial data cached |
| Intentional product use issue | 505 | 14.1 13.0–15.4ROR 15.0 · χ² 6,143 / p <1e-300 | 14.0 EB05 13.0 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 13.8 | no trial data cached |
| Somnolence (drowsiness) | 467 | 5.7 5.2–6.2ROR 6.0 · χ² 1,818 / p <1e-300 | 5.7 EB05 5.2 · IC025 +2.3 3/3 methods agree | No label text to screen | serious PRR 5.8 | no trial data cached |
| Vomiting | 439 | 2.3 2.1–2.5ROR 2.4 · χ² 326 / p 3e-73 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen | serious PRR 2.1 | no trial data cached |
| Feeling abnormal | 425 | 4.3 3.9–4.8ROR 4.5 · χ² 1,097 / p 8e-241 | 4.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen | serious PRR 5.8 | no trial data cached |
| Weight decreased (weight loss) | 403 | 3.5 3.2–3.9ROR 3.7 · χ² 741 / p 2e-163 | 3.5 EB05 3.2 · IC025 +1.7 3/3 methods agree | No label text to screen | serious PRR 3.4 | no trial data cached |
| Depression | 403 | 4.3 3.9–4.8ROR 4.5 · χ² 1,036 / p 1e-227 | 4.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen | serious PRR 3.8 | no trial data cached |
| Fall | 394 | 2.9 2.6–3.2ROR 3.0 · χ² 497 / p 2e-110 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen | serious PRR 2.3 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Oxybates?
In FDA FAERS, the most frequently co-reported reaction terms for Oxybates are nausea, anxiety, dizziness, headache, somnolence, vomiting. 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 Oxybates have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that Oxybates 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
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- 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, 1,006 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
Page generated 2026-10-08. 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.