Drug · FAERS side-effect profile with label screen
Oxide side effects: what 41,569 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Magnesium Oxide (Magnesium Oxide)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
41,569 reports · 80% serious · 6,506 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
relieves acid indigestion upset stomach
FDA label, Indications and Usage
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 5Lab value / disease marker 5No label text to screen 30
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). 1,175 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 |
|---|---|---|---|---|---|---|
| Antacid therapy | 49 | 347.6 241.3–500.7ROR 348.0 · calibrated p 1e-11 ✓ | 189.8 EB05 149.2 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious n=49 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Sleep disorder therapy | 75 | 341.6 254.6–458.4ROR 342.3 · calibrated p 7e-12 ✓ | 192.9 EB05 158.9 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious n=75 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Pulmonary vasculitis | 210 | 334.2 280.6–398.0ROR 335.9 · calibrated p 4e-12 ✓ | 196.6 EB05 175.3 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=210 · ♀ 0% (drug 56%) | not reported in cached trials |
| Vaginal flatulence | 118 | 318.4 252.8–401.2ROR 319.3 · calibrated p 9e-12 ✓ | 188.5 EB05 161.6 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=118 · ♀ 100% (drug 56%) · 91% clinician | not reported in cached trials |
| Total lung capacity abnormal | 122 | 238.5 192.2–295.9ROR 239.2 · calibrated p 1e-10 ✓ | 157.5 EB05 135.4 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=122 · ♀ 0% (drug 56%) | not reported in cached trials |
| Appendicolith | 99 | 178.1 141.6–224.0ROR 178.5 · calibrated p 2e-9 ✓ | 128.1 EB05 108.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=99 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Spirometry abnormal | 150 | 173.2 143.9–208.5ROR 173.8 · calibrated p 2e-9 ✓ | 126.6 EB05 110.5 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=150 · ♀ 0% (drug 56%) | not reported in cached trials |
| Analgesic therapy | 76 | 166.2 128.2–215.5ROR 166.5 · calibrated p 3e-9 ✓ | 121.1 EB05 99.9 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious n=76 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Mite allergy | 153 | 159.3 132.8–191.0ROR 159.8 · calibrated p 4e-9 ✓ | 119.1 EB05 104.1 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=152 · ♀ 0% (drug 56%) | not reported in cached trials |
| Drug therapy | 75 | 154.5 119.3–200.2ROR 154.8 · calibrated p 6e-9 ✓ | 114.7 EB05 94.5 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious n=75 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Congenital hiatus hernia | 47 | 135.7 98.3–187.3ROR 135.8 · calibrated p 2e-8 ✓ | 102.4 EB05 80.1 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=47 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Malignant melanoma stage 0 | 38 | 133.8 93.5–191.4ROR 133.9 · calibrated p 3e-8 ✓ | 100.4 EB05 76.4 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=38 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Capillaritis | 52 | 121.2 89.5–164.1ROR 121.4 · calibrated p 5e-8 ✓ | 94.3 EB05 74.7 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=52 · ♀ 0% (drug 56%) | not reported in cached trials |
| Mycotic allergy | 155 | 113.7 95.5–135.3ROR 114.1 · calibrated p 5e-8 ✓ | 91.7 EB05 80.2 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=154 · ♀ 0% (drug 56%) | not reported in cached trials |
| Anticoagulant therapy | 51 | 113.6 83.8–153.9ROR 113.7 · calibrated p 8e-8 ✓ | 89.6 EB05 70.8 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=51 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Dust allergy | 154 | 95.8 80.7–113.8ROR 96.2 · calibrated p 2e-7 ✓ | 79.7 EB05 69.7 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=153 · ♀ 0% (drug 56%) | not reported in cached trials |
| Antineutrophil cytoplasmic antibody positive | 107 | 86.8 70.7–106.6ROR 87.0 · calibrated p 4e-7 ✓ | 73.1 EB05 62.2 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=107 · ♀ 0% (drug 56%) | not reported in cached trials |
| Neuritis | 220 | 84.1 72.9–97.0ROR 84.5 · calibrated p 4e-7 ✓ | 71.6 EB05 64.0 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=220 · ♀ 0% (drug 56%) | not reported in cached trials |
| Hypermagnesaemia | 87 | 79.1 63.1–99.2ROR 79.3 · calibrated p 8e-7 ✓ | 67.4 EB05 56.3 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=87 · 100% clinician | not reported in cached trials |
| Granuloma skin | 99 | 68.4 55.4–84.3ROR 68.5 · calibrated p 2e-6 ✓ | 59.6 EB05 50.3 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=99 · ♀ 100% (drug 56%) | not reported in cached trials |
| Conjunctivitis allergic | 162 | 62.7 53.3–73.9ROR 63.0 · calibrated p 3e-6 ✓ | 55.5 EB05 48.7 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=161 · ♀ 0% (drug 56%) | not reported in cached trials |
| Eosinophilic granulomatosis with polyangiitis | 186 | 51.1 44.0–59.4ROR 51.3 · calibrated p 1e-5 ✓ | 46.2 EB05 40.9 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=186 · ♀ 0% (drug 56%) | not reported in cached trials |
| Respiratory symptom | 245 | 48.3 42.4–55.0ROR 48.6 · calibrated p 2e-5 ✓ | 43.9 EB05 39.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=244 · ♀ 0% (drug 56%) | not reported in cached trials |
| Female genital tract fistula | 142 | 45.3 38.1–53.8ROR 45.4 · calibrated p 3e-5 ✓ | 41.4 EB05 36.0 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=141 · ♀ 100% (drug 56%) | not reported in cached trials |
| Blood parathyroid hormone decreased | 104 | 37.7 30.9–46.1ROR 37.8 · calibrated p 8e-5 ✓ | 34.9 EB05 29.7 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=103 · ♀ 100% (drug 56%) | not reported in cached trials |
| Normochromic normocytic anaemia | 175 | 31.2 26.8–36.3ROR 31.3 · calibrated p 2e-4 ✓ | 29.3 EB05 25.8 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=175 · ♀ 0% (drug 56%) | not reported in cached trials |
| Radiculopathy | 145 | 29.3 24.8–34.6ROR 29.4 · calibrated p 3e-4 ✓ | 27.6 EB05 24.1 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=144 · ♀ 100% (drug 56%) | not reported in cached trials |
| Hyperphosphataemia | 115 | 28.9 23.9–34.8ROR 29.0 · calibrated p 4e-4 ✓ | 27.2 EB05 23.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=114 · ♀ 16% (drug 56%) · 100% clinician | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 43 | 24.8 18.2–33.6ROR 24.8 · calibrated p 9e-4 ✓ | 23.4 EB05 18.1 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=43 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Pulmonary alveolar haemorrhage | 258 | 24.3 21.5–27.5ROR 24.5 · calibrated p 8e-4 ✓ | 23.2 EB05 20.9 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=257 · ♀ 0% (drug 56%) | not reported in cached trials |
| Panniculitis | 111 | 24.3 20.1–29.4ROR 24.4 · calibrated p 9e-4 ✓ | 23.1 EB05 19.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=111 · ♀ 100% (drug 56%) | not reported in cached trials |
| Chronic sinusitis | 171 | 24.1 20.7–28.1ROR 24.2 · calibrated p 9e-4 ✓ | 23.0 EB05 20.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=169 · ♀ 100% (drug 56%) | not reported in cached trials |
| Proctitis | 124 | 23.3 19.5–27.9ROR 23.4 · calibrated p 0.001 ✓ | 22.2 EB05 19.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=124 · ♀ 100% (drug 56%) | not reported in cached trials |
| Forced expiratory volume decreased | 125 | 23.2 19.4–27.8ROR 23.3 · calibrated p 0.001 ✓ | 22.1 EB05 19.1 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=125 · ♀ 0% (drug 56%) | not reported in cached trials |
| Blood phosphorus increased | 117 | 22.6 18.8–27.2ROR 22.6 · calibrated p 0.001 ✓ | 21.6 EB05 18.5 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=112 · ♀ 17% (drug 56%) · 91% clinician | not reported in cached trials |
| Nephrogenic anaemia | 200 | 22.5 19.5–25.9ROR 22.6 · calibrated p 0.001 ✓ | 21.5 EB05 19.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=199 · 100% clinician | not reported in cached trials |
| Upper respiratory tract inflammation | 50 | 21.8 16.4–28.9ROR 21.8 · calibrated p 0.002 ✓ | 20.8 EB05 16.4 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=49 · 100% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 44 | 21.5 15.9–29.0ROR 21.5 · calibrated p 0.002 ✓ | 20.4 EB05 15.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 | not reported in cached trials |
| Neurological symptom | 218 | 20.1 17.6–23.0ROR 20.2 · calibrated p 0.002 ✓ | 19.3 EB05 17.3 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=216 · ♀ 0% (drug 56%) | not reported in cached trials |
| Rheumatoid nodule | 105 | 19.7 16.2–24.0ROR 19.8 · calibrated p 0.002 ✓ | 18.9 EB05 16.1 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=105 · ♀ 100% (drug 56%) | 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 Oxide 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).
- NCT00430989 — The ENIGMA II Trial:Nitrous Oxide Anaesthesia and Cardiac Morbidity After Major Surgery: a Randomised Controll (N=7112, PHASE4; 13 AE terms posted; arms: Nitrous Oxide: 70% N2O; Nitrous Oxide Free)
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 | 2,932 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.913 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | not reported in cached trials |
| Diarrhoea (diarrhea) | 2,714 | 2.1 2.1–2.2ROR 2.2 · calibrated p 0.946 | 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 2.0 | not reported in cached trials |
| Fatigue (tiredness) | 2,567 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.777 | 1.7 EB05 1.6 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 2,185 | 2.0 1.9–2.0ROR 2.0 · calibrated p 0.946 | 1.9 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | not reported in cached trials |
| Pneumonia (lung infection) | 2,110 | 3.3 3.2–3.4ROR 3.4 · calibrated p 0.502 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | not reported in cached trials |
| Off label use (used outside approved label) | 2,105 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.464 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.3 | not reported in cached trials |
| Pyrexia (fever) | 1,897 | 2.8 2.7–2.9ROR 2.9 · calibrated p 0.675 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | not reported in cached trials |
| Vomiting | 1,748 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.901 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | not reported in cached trials |
| Headache | 1,703 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.568 | 1.4 EB05 1.3 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | not reported in cached trials |
| Death | 1,666 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.290 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.7 | NCT00430989: 57/3,509 (1.6%) on Oxide (serious AE) |
| Anaemia (low red blood cells) | 1,529 | 4.1 3.9–4.3ROR 4.2 · calibrated p 0.346 | 4.0 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | not reported in cached trials |
| Pain | 1,528 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.483 | 1.3 EB05 1.2 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious PRR 1.2 | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,515 | 0.6 0.6–0.6ROR 0.6 · calibrated p 0.070 | 0.6 EB05 0.6 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | not reported in cached trials |
| Decreased appetite (loss of appetite) | 1,506 | 3.3 3.1–3.5ROR 3.4 · calibrated p 0.515 | 3.3 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 | not reported in cached trials |
| Constipation | 1,485 | 3.5 3.3–3.7ROR 3.6 · calibrated p 0.468 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | not reported in cached trials |
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 Oxide?
In FDA FAERS, the most frequently co-reported reaction terms for Oxide are nausea, diarrhoea, fatigue, dyspnoea, pneumonia, pyrexia. 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 Oxide have an FDA boxed warning?
No. The FDA label retrieved for Oxide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that 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 31bc45c7-ba92-bad0-e063-6394a90a9af8, effective 20250401; matched on
openfda.generic_name.exact:"MAGNESIUM OXIDE") - 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, 1,215 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
OXIDE, 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.