Drug · FAERS side-effect profile with label screen
0Xygen side effects: what 48,783 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Oxygen
openFDA label
Who reports
48,783 reports · 67% serious · 7,162 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
Boxed warning
None in the current label
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 9Lab value / disease marker 3No label text to screen 28
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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 1,202 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 |
|---|---|---|---|---|---|---|
| Device wireless communication issue | 101 | 291.6 226.3–375.8ROR 292.2 · χ² 17,119 / p <1e-300 | 167.4 EB05 141.7 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious n=33 · 100% consumer | no trial arm names this drug |
| Device maintenance issue | 157 | 165.5 137.6–199.0ROR 166.0 · χ² 18,313 / p <1e-300 | 117.4 EB05 102.8 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious n=62 · 100% consumer | no trial arm names this drug |
| Post-tussive vomiting | 37 | 133.3 92.1–192.9ROR 133.4 · χ² 3,591 / p <1e-300 | 96.6 EB05 73.2 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | ♀ 100% (drug 65%) · 100% consumer | no trial arm names this drug |
| Oxygen consumption increased | 518 | 120.5 109.3–132.8ROR 121.8 · χ² 47,657 / p <1e-300 | 93.6 EB05 87.1 · IC025 +6.3 3/3 methods agree | Lab value / disease marker | serious n=386 | no trial arm names this drug |
| Patient dissatisfaction with device | 50 | 113.9 83.4–155.7ROR 114.1 · χ² 4,318 / p <1e-300 | 87.0 EB05 68.6 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial arm names this drug |
| Bendopnoea | 34 | 83.8 58.0–121.1ROR 83.9 · χ² 2,252 / p <1e-300 | 67.5 EB05 50.5 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial arm names this drug |
| Dependence on oxygen therapy | 72 | 75.5 58.8–97.0ROR 75.6 · χ² 4,426 / p <1e-300 | 63.2 EB05 51.8 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=66 | no trial arm names this drug |
| Pulmonary arterial pressure abnormal | 38 | 65.1 46.3–91.6ROR 65.2 · χ² 2,023 / p <1e-300 | 55.1 EB05 41.9 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=30 · ♀ 100% (drug 65%) · 100% clinician | no trial arm names this drug |
| Oxygen supplementation | 97 | 63.7 51.5–78.8ROR 63.8 · χ² 5,146 / p <1e-300 | 54.9 EB05 46.3 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=69 · 81% consumer | no trial arm names this drug |
| Infusion site discharge | 214 | 61.2 53.0–70.6ROR 61.5 · χ² 11,015 / p <1e-300 | 53.3 EB05 47.6 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=88 · 90% consumer | no trial arm names this drug |
| Walking distance test abnormal | 45 | 56.5 41.4–77.1ROR 56.5 · χ² 2,113 / p <1e-300 | 48.9 EB05 38.1 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=34 | no trial arm names this drug |
| Catheter site pruritus | 98 | 53.9 43.7–66.5ROR 54.0 · χ² 4,467 / p <1e-300 | 47.5 EB05 40.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=80 · ♀ 86% (drug 65%) | no trial arm names this drug |
| Infusion site infection | 242 | 51.1 44.8–58.4ROR 51.4 · χ² 10,565 / p <1e-300 | 45.6 EB05 40.9 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=126 · 79% consumer | no trial arm names this drug |
| Catheter site rash | 47 | 49.8 36.8–67.3ROR 49.8 · χ² 1,966 / p <1e-300 | 43.9 EB05 34.3 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 · ♀ 100% (drug 65%) | no trial arm names this drug |
| Infusion site irritation | 123 | 47.0 39.0–56.6ROR 47.1 · χ² 4,938 / p <1e-300 | 42.1 EB05 36.2 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=46 · 87% consumer | no trial arm names this drug |
| Infusion site haemorrhage | 313 | 45.7 40.7–51.4ROR 46.0 · χ² 12,313 / p <1e-300 | 41.2 EB05 37.6 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=102 · 90% consumer | no trial arm names this drug |
| Retinopathy of prematurity | 51 | 43.7 32.8–58.3ROR 43.7 · χ² 1,889 / p <1e-300 | 39.2 EB05 30.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=51 · 100% clinician | no trial arm names this drug |
| Device infusion issue | 226 | 43.5 37.9–49.8ROR 43.7 · χ² 8,462 / p <1e-300 | 39.4 EB05 35.3 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious n=101 · 85% consumer | no trial arm names this drug |
| Infusion site induration | 129 | 42.7 35.6–51.1ROR 42.8 · χ² 4,731 / p <1e-300 | 38.6 EB05 33.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=37 · 100% consumer | no trial arm names this drug |
| Infusion site inflammation | 61 | 42.5 32.7–55.3ROR 42.6 · χ² 2,208 / p <1e-300 | 38.3 EB05 30.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial arm names this drug |
| Cerebral artery thrombosis | 46 | 41.8 30.9–56.6ROR 41.8 · χ² 1,629 / p <1e-300 | 37.6 EB05 29.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=46 · ♀ 0% (drug 65%) · 100% clinician | no trial arm names this drug |
| Oxygen therapy | 145 | 41.8 35.2–49.5ROR 41.9 · χ² 5,215 / p <1e-300 | 37.9 EB05 33.0 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=134 | no trial arm names this drug |
| Infusion site warmth | 107 | 41.8 34.2–50.9ROR 41.9 · χ² 3,837 / p <1e-300 | 37.9 EB05 32.2 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=46 · 100% consumer | no trial arm names this drug |
| Chronic respiratory failure | 101 | 39.6 32.3–48.6ROR 39.7 · χ² 3,442 / p <1e-300 | 36.1 EB05 30.6 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=98 | no trial arm names this drug |
| Pulmonary arterial pressure increased | 137 | 39.1 32.8–46.6ROR 39.2 · χ² 4,620 / p <1e-300 | 35.7 EB05 31.0 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=124 | no trial arm names this drug |
| Brain scan abnormal | 46 | 38.2 28.3–51.7ROR 38.3 · χ² 1,496 / p <1e-300 | 34.7 EB05 27.1 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=46 · ♀ 0% (drug 65%) · 100% clinician | no trial arm names this drug |
| Pulmonary veno-occlusive disease | 56 | 37.4 28.5–49.2ROR 37.5 · χ² 1,790 / p <1e-300 | 34.1 EB05 27.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=56 · 100% clinician | no trial arm names this drug |
| Cor pulmonale | 76 | 36.6 28.9–46.2ROR 36.6 · χ² 2,387 / p <1e-300 | 33.5 EB05 27.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=75 | no trial arm names this drug |
| Infusion site pain | 1,000 | 36.3 34.1–38.7ROR 37.1 · χ² 31,620 / p <1e-300 | 33.5 EB05 31.8 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=365 · 87% consumer | no trial arm names this drug |
| Catheter site discharge | 86 | 36.3 29.1–45.2ROR 36.3 · χ² 2,682 / p <1e-300 | 33.2 EB05 27.8 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=64 | no trial arm names this drug |
| Infusion site erythema | 631 | 35.2 32.5–38.2ROR 35.7 · χ² 19,342 / p <1e-300 | 32.6 EB05 30.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=237 · 87% consumer | no trial arm names this drug |
| Right ventricular failure | 530 | 34.7 31.8–37.9ROR 35.1 · χ² 15,993 / p <1e-300 | 32.1 EB05 29.9 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.5 | no trial arm names this drug |
| Device electrical finding | 52 | 33.8 25.5–44.9ROR 33.9 · χ² 1,503 / p <1e-300 | 31.1 EB05 24.6 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial arm names this drug |
| Catheter management | 66 | 33.7 26.2–43.3ROR 33.8 · χ² 1,910 / p <1e-300 | 31.1 EB05 25.3 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=66 · 100% clinician | no trial arm names this drug |
| Transplant evaluation | 37 | 33.4 23.9–46.7ROR 33.4 · χ² 1,048 / p 4e-230 | 30.6 EB05 23.2 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=38 · 100% clinician | no trial arm names this drug |
| Infusion site nodule | 65 | 33.3 25.8–42.8ROR 33.3 · χ² 1,855 / p <1e-300 | 30.6 EB05 24.9 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | ♀ 100% (drug 65%) · 100% consumer | no trial arm names this drug |
| Dizziness exertional | 52 | 32.1 24.2–42.6ROR 32.2 · χ² 1,429 / p <1e-300 | 29.6 EB05 23.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=36 · 100% consumer | no trial arm names this drug |
| Catheter site erythema | 145 | 31.8 26.9–37.6ROR 31.9 · χ² 3,994 / p <1e-300 | 29.5 EB05 25.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=115 | no trial arm names this drug |
| Infusion site cellulitis | 35 | 31.8 22.6–44.8ROR 31.8 · χ² 942 / p 3e-207 | 29.2 EB05 22.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial arm names this drug |
| Pulmonary arterial hypertension | 944 | 29.6 27.8–31.6ROR 30.2 · χ² 24,389 / p <1e-300 | 27.7 EB05 26.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.2 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for 0Xygen (searched 0XYGEN).
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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 9,766 | 7.5 7.4–7.6ROR 9.1 · χ² 55,619 / p <1e-300 | 7.4 EB05 7.3 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 | no trial arm names this drug |
| Cough | 5,044 | 7.8 7.6–8.1ROR 8.6 · χ² 29,965 / p <1e-300 | 7.7 EB05 7.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 · 72% consumer | no trial arm names this drug |
| Headache | 4,809 | 3.3 3.2–3.4ROR 3.6 · χ² 7,913 / p <1e-300 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.4 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 4,253 | 2.8 2.8–2.9ROR 3.0 · χ² 5,208 / p <1e-300 | 2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial arm names this drug |
| Fatigue (tiredness) | 4,082 | 2.3 2.2–2.3ROR 2.4 · χ² 2,950 / p <1e-300 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | no trial arm names this drug |
| Nausea | 3,914 | 2.1 2.1–2.2ROR 2.2 · χ² 2,425 / p <1e-300 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | no trial arm names this drug |
| Pneumonia (lung infection) | 3,902 | 5.2 5.1–5.4ROR 5.6 · χ² 13,354 / p <1e-300 | 5.2 EB05 5.0 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 | no trial arm names this drug |
| Dizziness | 3,437 | 3.0 2.9–3.1ROR 3.1 · χ² 4,566 / p <1e-300 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | no trial arm names this drug |
| Oxygen saturation decreased | 3,050 | 24.7 23.9–25.6ROR 26.3 · χ² 65,712 / p <1e-300 | 23.4 EB05 22.7 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 18.6 | no trial arm names this drug |
| Death | 2,581 | 1.3 1.2–1.3ROR 1.3 · χ² 168 / p 8e-39 | 1.3 EB05 1.2 · IC025 +0.3 | Outcome field, not a reaction | serious PRR 1.1 | no trial arm names this drug |
| Malaise (feeling unwell) | 2,336 | 2.3 2.2–2.4ROR 2.3 · χ² 1,709 / p <1e-300 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | no trial arm names this drug |
| Hypotension (low blood pressure) | 2,316 | 5.0 4.8–5.2ROR 5.2 · χ² 7,387 / p <1e-300 | 4.9 EB05 4.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial arm names this drug |
| Asthenia (weakness) | 2,314 | 2.6 2.5–2.8ROR 2.7 · χ² 2,394 / p <1e-300 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | no trial arm names this drug |
| Off label use (used outside approved label) | 2,260 | 1.1 1.1–1.2ROR 1.1 · χ² 28 / p 6e-8 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.3 | no trial arm names this drug |
| Weight decreased (weight loss) | 2,087 | 3.2 3.1–3.4ROR 3.3 · χ² 3,210 / p <1e-300 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial arm names this drug |
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 0Xygen?
In FDA FAERS, the most frequently co-reported reaction terms for 0Xygen are dyspnoea, cough, headache, diarrhoea, fatigue, nausea. 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 0Xygen have an FDA boxed warning?
No. The FDA label retrieved for 0Xygen has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that 0Xygen 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 dbec9c5c-4656-4238-861a-986e8bd10e53, effective 20241006; matched on
openfda.generic_name.exact:"0XYGEN" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 1,242 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
0XYGEN, results-bearing studies sorted by enrollment)
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.