Drug · FAERS side-effect profile with label screen
Nitrous Oxide side effects: what 2,189 FDA adverse event reports show
Drug class
Not stated in label
Who reports
2,189 reports · 94% serious · 222 with death outcome · 49% 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 3Lab value / disease marker 1No label text to screen 36
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. 55 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 |
|---|---|---|---|---|---|---|
| Ventricular fibrillation | 43 | 37.1 27.6–49.9ROR 37.8 · χ² 1,469 / p <1e-300 | 36.4 EB05 28.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.1 · 96% clinician | no trial data cached |
| Ventricular tachycardia | 44 | 25.5 19.0–34.1ROR 26.0 · χ² 1,008 / p 1e-221 | 25.2 EB05 19.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.4 · 92% clinician | no trial data cached |
| Sinus tachycardia | 33 | 22.3 15.9–31.3ROR 22.7 · χ² 650 / p 1e-143 | 22.0 EB05 16.4 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.9 · ♀ 76% (drug 49%) · 100% clinician | no trial data cached |
| Respiratory depression | 27 | 21.1 14.5–30.7ROR 21.4 · χ² 497 / p 3e-110 | 20.8 EB05 14.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.3 · 100% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 101 | 18.2 15.1–22.1ROR 19.1 · χ² 1,628 / p <1e-300 | 18.1 EB05 15.3 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.1 · 95% clinician | no trial data cached |
| Brain oedema | 22 | 16.7 11.0–25.3ROR 16.9 · χ² 309 / p 2e-69 | 16.3 EB05 11.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 · ♀ 90% (drug 49%) · 90% clinician | no trial data cached |
| Mydriasis | 22 | 16.5 10.9–24.9ROR 16.6 · χ² 304 / p 3e-68 | 16.0 EB05 10.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.0 · 95% clinician | no trial data cached |
| Polyneuropathy | 20 | 16.1 10.4–24.9ROR 16.3 · χ² 268 / p 1e-60 | 15.6 EB05 10.3 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 · 95% clinician | no trial data cached |
| Drug abuse | 136 | 15.6 13.2–18.3ROR 16.5 · χ² 1,846 / p <1e-300 | 15.5 EB05 13.4 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · ♀ 25% (drug 49%) | no trial data cached |
| Ataxia | 19 | 15.3 9.8–23.9ROR 15.4 · χ² 239 / p 3e-54 | 14.7 EB05 9.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.1 | no trial data cached |
| Cardiac arrest (heart stopping) | 121 | 14.0 11.8–16.6ROR 14.8 · χ² 1,451 / p <1e-300 | 13.9 EB05 11.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 · 96% clinician | no trial data cached |
| Euphoric mood | 15 | 14.0 8.4–23.1ROR 14.0 · χ² 167 / p 1e-38 | 12.9 EB05 7.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Ventricular extrasystoles | 15 | 13.8 8.3–22.9ROR 13.9 · χ² 166 / p 3e-38 | 12.8 EB05 7.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| Sinus bradycardia | 13 | 12.9 7.5–22.1ROR 12.9 · χ² 130 / p 2e-30 | 11.5 EB05 6.4 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.1 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 21 | 12.8 8.3–19.5ROR 12.9 · χ² 216 / p 3e-49 | 12.0 EB05 7.8 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 · ♀ 24% (drug 49%) | no trial data cached |
| Motor dysfunction | 13 | 12.3 7.2–21.2ROR 12.4 · χ² 124 / p 4e-29 | 10.8 EB05 6.1 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.5 | no trial data cached |
| Caesarean section | 15 | 12.2 7.4–20.2ROR 12.3 · χ² 143 / p 2e-33 | 11.0 EB05 6.5 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Dystonia | 24 | 11.8 7.9–17.6ROR 11.9 · χ² 227 / p 1e-51 | 11.1 EB05 7.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 · 96% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 17 | 11.4 7.1–18.3ROR 11.5 · χ² 151 / p 6e-35 | 10.2 EB05 6.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 | no trial data cached |
| Hypothermia | 12 | 11.3 6.4–19.9ROR 11.4 · χ² 103 / p 2e-24 | 9.6 EB05 5.3 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 | no trial data cached |
| Muscle rigidity | 14 | 11.2 6.7–18.9ROR 11.3 · χ² 120 / p 3e-28 | 9.8 EB05 5.7 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 | no trial data cached |
| Obstructive airways disorder | 13 | 11.2 6.5–19.2ROR 11.2 · χ² 110 / p 4e-26 | 9.6 EB05 5.4 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 | no trial data cached |
| Hypoxia (low oxygen) | 40 | 10.9 8.0–14.9ROR 11.1 · χ² 351 / p 1e-78 | 10.5 EB05 7.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 · 92% clinician | no trial data cached |
| Aspiration | 12 | 10.6 6.0–18.7ROR 10.7 · χ² 95 / p 9e-23 | 8.9 EB05 5.0 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Cardiogenic shock | 15 | 10.1 6.1–16.7ROR 10.1 · χ² 114 / p 8e-27 | 8.7 EB05 5.2 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Serotonin syndrome | 20 | 10.0 6.5–15.5ROR 10.1 · χ² 153 / p 2e-35 | 9.0 EB05 5.9 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 · 95% clinician | no trial data cached |
| Pulmonary oedema | 45 | 9.6 7.2–12.8ROR 9.8 · χ² 339 / p 5e-76 | 9.2 EB05 7.0 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 · 95% clinician | no trial data cached |
| Blood iron decreased | 11 | 8.9 5.0–16.1ROR 9.0 · χ² 70 / p 3e-17 | 7.1 EB05 4.0 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 7.4 | no trial data cached |
| Hallucination, visual | 19 | 8.7 5.5–13.6ROR 8.7 · χ² 121 / p 2e-28 | 7.6 EB05 5.0 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 | no trial data cached |
| Depressed level of consciousness | 35 | 8.5 6.1–11.8ROR 8.6 · χ² 224 / p 6e-51 | 7.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 · ♀ 74% (drug 49%) | no trial data cached |
| Neurotoxicity | 15 | 8.3 5.0–13.7ROR 8.3 · χ² 89 / p 2e-21 | 7.0 EB05 4.3 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | no trial data cached |
| Hyperkalaemia (high potassium) | 30 | 8.2 5.8–11.7ROR 8.3 · χ² 184 / p 4e-42 | 7.5 EB05 5.5 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 · 100% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 14 | 8.2 4.9–13.8ROR 8.2 · χ² 81 / p 9e-20 | 6.8 EB05 4.2 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | no trial data cached |
| Myoclonus | 10 | 8.0 4.3–14.9ROR 8.1 · χ² 55 / p 7e-14 | 6.3 EB05 3.5 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Drug interaction | 133 | 8.0 6.8–9.5ROR 8.5 · χ² 817 / p 6e-180 | 7.9 EB05 6.8 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 92% clinician | no trial data cached |
| Post procedural complication | 16 | 8.0 4.9–13.0ROR 8.0 · χ² 91 / p 9e-22 | 6.8 EB05 4.3 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 | no trial data cached |
| Anaphylactic shock | 21 | 7.8 5.1–12.0ROR 7.9 · χ² 119 / p 6e-28 | 6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| Circulatory collapse | 14 | 7.8 4.6–13.2ROR 7.9 · χ² 77 / p 9e-19 | 6.5 EB05 4.0 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | no trial data cached |
| Respiratory arrest | 22 | 7.6 5.0–11.5ROR 7.6 · χ² 119 / p 5e-28 | 6.7 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 · ♀ 29% (drug 49%) | no trial data cached |
| Premature baby | 22 | 7.0 4.6–10.6ROR 7.0 · χ² 107 / p 2e-25 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 · 95% clinician | 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 |
|---|---|---|---|---|---|---|
| Drug abuse | 136 | 15.6 13.2–18.3ROR 16.5 · χ² 1,846 / p <1e-300 | 15.5 EB05 13.4 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · ♀ 25% (drug 49%) | no trial data cached |
| Drug interaction | 133 | 8.0 6.8–9.5ROR 8.5 · χ² 817 / p 6e-180 | 7.9 EB05 6.8 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 92% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 121 | 14.0 11.8–16.6ROR 14.8 · χ² 1,451 / p <1e-300 | 13.9 EB05 11.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 · 96% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 101 | 18.2 15.1–22.1ROR 19.1 · χ² 1,628 / p <1e-300 | 18.1 EB05 15.3 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.1 · 95% clinician | no trial data cached |
| Toxicity to various agents | 82 | 4.7 3.8–5.8ROR 4.8 · χ² 235 / p 2e-53 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 · 95% clinician | no trial data cached |
| Drug dependence | 50 | 2.9 2.2–3.9ROR 3.0 · χ² 63 / p 1e-15 | 2.9 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · ♀ 27% (drug 49%) · 94% clinician | no trial data cached |
| Pulmonary oedema | 45 | 9.6 7.2–12.8ROR 9.8 · χ² 339 / p 5e-76 | 9.2 EB05 7.0 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 · 95% clinician | no trial data cached |
| Ventricular tachycardia | 44 | 25.5 19.0–34.1ROR 26.0 · χ² 1,008 / p 1e-221 | 25.2 EB05 19.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.4 · 92% clinician | no trial data cached |
| Ventricular fibrillation | 43 | 37.1 27.6–49.9ROR 37.8 · χ² 1,469 / p <1e-300 | 36.4 EB05 28.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.1 · 96% clinician | no trial data cached |
| Agitation | 42 | 5.5 4.0–7.4ROR 5.5 · χ² 149 / p 1e-34 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 · 92% clinician | no trial data cached |
| Oxygen saturation decreased | 40 | 6.9 5.0–9.3ROR 7.0 · χ² 195 / p 1e-44 | 6.4 EB05 4.9 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 4.5 · 100% clinician | no trial data cached |
| Hypoxia (low oxygen) | 40 | 10.9 8.0–14.9ROR 11.1 · χ² 351 / p 1e-78 | 10.5 EB05 7.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 · 92% clinician | no trial data cached |
| Foetal exposure during pregnancy | 37 | 4.4 3.2–6.0ROR 4.4 · χ² 93 / p 3e-22 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · 97% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 36 | 6.3 4.5–8.7ROR 6.4 · χ² 155 / p 8e-36 | 5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Depressed level of consciousness | 35 | 8.5 6.1–11.8ROR 8.6 · χ² 224 / p 6e-51 | 7.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 · ♀ 74% (drug 49%) | 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 Nitrous Oxide?
In FDA FAERS, the most frequently co-reported reaction terms for Nitrous Oxide are cardiac arrest, bradycardia, toxicity to various agents, pulmonary oedema, ventricular tachycardia, ventricular fibrillation. 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 Nitrous Oxide have an FDA boxed warning?
No. The FDA label retrieved for Nitrous Oxide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nitrous Oxide 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 00d2e785-1cdc-496d-abd3-b255ae1cb693, effective 20251013; matched on
openfda.generic_name.exact:"NITROUS OXIDE" 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, 95 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.