Oxygen side effects: what 48,786 FDA adverse event reports show

Oxygen · 1,241 reaction terms · 256,326 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

48,786 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, 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). 1,201 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

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 · calibrated p 2e-11 ✓	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	165.5 137.6–198.9ROR 166.0 · calibrated p 3e-9 ✓	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 · calibrated p 3e-8 ✓	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 · calibrated p 3e-8 ✓	93.6 EB05 87.0 · 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 114.0 · calibrated p 8e-8 ✓	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 · calibrated p 9e-7 ✓	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 · calibrated p 1e-6 ✓	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 · calibrated p 4e-6 ✓	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 · calibrated p 4e-6 ✓	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 · calibrated p 4e-6 ✓	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 41.4–77.0ROR 56.5 · calibrated p 1e-5 ✓	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 · calibrated p 1e-5 ✓	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 · calibrated p 1e-5 ✓	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 · calibrated p 2e-5 ✓	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 · calibrated p 2e-5 ✓	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 · calibrated p 2e-5 ✓	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 · calibrated p 4e-5 ✓	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 · calibrated p 3e-5 ✓	39.4 EB05 35.2 · 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 · calibrated p 4e-5 ✓	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 · calibrated p 5e-5 ✓	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 · calibrated p 6e-5 ✓	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 · calibrated p 4e-5 ✓	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 · calibrated p 5e-5 ✓	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 · calibrated p 6e-5 ✓	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 · calibrated p 7e-5 ✓	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 · calibrated p 1e-4 ✓	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 · calibrated p 1e-4 ✓	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 · calibrated p 1e-4 ✓	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 · calibrated p 8e-5 ✓	33.5 EB05 31.8 · IC025 +4.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 29.6 · serious n=365 · 87% consumer	no trial arm names this drug
Catheter site discharge	86	36.3 29.1–45.2ROR 36.3 · calibrated p 1e-4 ✓	33.2 EB05 27.7 · 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 · calibrated p 1e-4 ✓	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 35.0 · calibrated p 1e-4 ✓	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 · calibrated p 2e-4 ✓	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 · calibrated p 2e-4 ✓	31.0 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 · calibrated p 2e-4 ✓	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 · calibrated p 2e-4 ✓	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 · calibrated p 2e-4 ✓	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 · calibrated p 2e-4 ✓	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 · calibrated p 3e-4 ✓	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 · calibrated p 3e-4 ✓	27.7 EB05 26.3 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 28.1 · serious PRR 24.2	no trial arm names this drug

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Interstitial lung disease	1,004	4.54.2–4.8	signal
Heart failure	1,825	4.44.2–4.6	signal
Serious infection	5,890	3.33.2–3.4	signal
Arrhythmia / qt	1,260	2.82.6–3.0	signal
Fall / fracture	2,066	2.32.2–2.4	signal
Anaemia	1,594	2.32.2–2.4	signal
Gi bleeding	811	1.91.8–2.0	raised
Venous thromboembolism	872	1.71.6–1.8	raised
Hyponatraemia	295	1.61.4–1.8	raised
Thrombocytopenia	769	1.51.4–1.6	raised
Kidney injury	1,548	1.51.4–1.5	raised
Opportunistic infection	418	1.31.2–1.4	raised
Myocardial infarction	556	1.21.1–1.3	raised
Hypoglycaemia	247	1.11.0–1.3	no difference
Liver injury	728	1.01.0–1.1	no difference
Depression	660	1.00.9–1.1	no difference

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Oxygen only as a background or rescue medication (NCT01256658, NCT00430989); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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 · calibrated p 0.044 ✓	7.4 EB05 7.3 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 6.4 · serious PRR 6.5	no trial arm names this drug
Cough	5,044	7.8 7.6–8.1ROR 8.6 · calibrated p 0.052	7.7 EB05 7.5 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 5.5 · serious PRR 6.6 · 72% consumer	no trial arm names this drug
Headache	4,809	3.3 3.2–3.4ROR 3.6 · calibrated p 0.471	3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 3.1 · serious PRR 3.4	no trial arm names this drug
Diarrhoea (diarrhea)	4,253	2.8 2.8–2.9ROR 3.0 · calibrated p 0.620	2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.3 · serious PRR 2.7	no trial arm names this drug
Fatigue (tiredness)	4,083	2.3 2.2–2.3ROR 2.4 · calibrated p 0.870	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.0 · serious PRR 2.5	no trial arm names this drug
Nausea	3,914	2.1 2.1–2.2ROR 2.2 · calibrated p 0.938	2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.0 · serious PRR 2.3	no trial arm names this drug
Pneumonia (lung infection)	3,902	5.2 5.1–5.4ROR 5.6 · calibrated p 0.180	5.2 EB05 5.0 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 4.6 · serious PRR 4.6	no trial arm names this drug
Dizziness	3,437	3.0 2.9–3.1ROR 3.1 · calibrated p 0.589	3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.5 · serious PRR 2.9	no trial arm names this drug
Oxygen saturation decreased	3,050	24.7 23.9–25.6ROR 26.3 · calibrated p 5e-4 ✓	23.4 EB05 22.7 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	age-adj. PRR 19.3 · serious PRR 18.6	no trial arm names this drug
Death	2,581	1.3 1.2–1.3ROR 1.3 · calibrated p 0.508	1.3 EB05 1.2 · IC025 +0.3	Outcome field, not a reaction	age-adj. PRR 1.4 · serious PRR 1.1	no trial arm names this drug
Malaise (feeling unwell)	2,336	2.3 2.2–2.4ROR 2.3 · calibrated p 0.881	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.3 · serious PRR 2.5	no trial arm names this drug
Hypotension (low blood pressure)	2,316	5.0 4.8–5.2ROR 5.2 · calibrated p 0.214	4.9 EB05 4.8 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 4.0 · serious PRR 4.0	no trial arm names this drug
Asthenia (weakness)	2,314	2.6 2.5–2.8ROR 2.7 · calibrated p 0.722	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.2 · 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 · calibrated p 0.387	1.1 EB05 1.1 · IC025 +0.1	Reporting / coding artifact	age-adj. PRR 1.1 · serious PRR 1.3	no trial arm names this drug
Weight decreased (weight loss)	2,087	3.2 3.1–3.4ROR 3.3 · calibrated p 0.532	3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.7 · 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 Oxygen?

In FDA FAERS, the most frequently co-reported reaction terms for Oxygen 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 Oxygen have an FDA boxed warning?

No. The FDA label retrieved for Oxygen has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Oxygen 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 007530ff-787e-4f37-bc9c-23193d006708, effective 20251009; matched on openfda.generic_name.exact:"OXYGEN" 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, field patient.drug.openfda.generic_name.exact, 1,241 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 OXYGEN, 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.