Drug · FAERS side-effect profile with label screen
Sulfur Hexafluoride side effects: what 1,847 FDA adverse event reports show
Drug class
No validated FDA label found
closest label found was a multi-ingredient product (Belladonna Leaf,Calcium Carbonate,Chamomile,Lycopodium Clavatum Spore,Anemone Patens Whole,Sulfur) and was not used
Who reports
1,847 reports · 70% serious · 91 with death outcome · 39% 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
Lab value / disease marker 4No label text to screen 36
What the badges mean
- 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. 9 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 |
|---|---|---|---|---|---|---|
| Unresponsive to stimuli | 119 | 52.2 43.9–62.2ROR 55.7 · χ² 5,910 / p <1e-300 | 51.6 EB05 44.3 · IC025 +5.1 3/3 methods agree | No label text to screen | serious PRR 43.8 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 243 | 50.0 44.4–56.2ROR 57.3 · χ² 11,588 / p <1e-300 | 49.6 EB05 44.5 · IC025 +5.3 3/3 methods agree | No label text to screen | serious PRR 41.4 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 47 | 33.6 25.3–44.6ROR 34.5 · χ² 1,452 / p <1e-300 | 33.1 EB05 25.9 · IC025 +4.2 3/3 methods agree | No label text to screen | serious PRR 26.8 · ♀ 60% (drug 39%) | no trial data cached |
| Anaphylactic shock | 61 | 26.8 21.0–34.3ROR 27.7 · χ² 1,489 / p <1e-300 | 26.6 EB05 21.4 · IC025 +4.0 3/3 methods agree | No label text to screen | serious PRR 22.2 | no trial data cached |
| Feeling hot | 136 | 25.0 21.2–29.4ROR 26.9 · χ² 3,107 / p <1e-300 | 24.8 EB05 21.5 · IC025 +4.2 3/3 methods agree | No label text to screen | serious PRR 24.7 | no trial data cached |
| Presyncope (near-fainting) | 52 | 24.2 18.5–31.7ROR 24.9 · χ² 1,133 / p 1e-248 | 24.0 EB05 19.0 · IC025 +3.8 3/3 methods agree | No label text to screen | serious PRR 17.2 | no trial data cached |
| Pallor | 51 | 21.1 16.1–27.6ROR 21.6 · χ² 954 / p 1e-209 | 20.9 EB05 16.5 · IC025 +3.7 3/3 methods agree | No label text to screen | serious PRR 19.5 | no trial data cached |
| Blood pressure decreased | 120 | 20.4 17.1–24.2ROR 21.7 · χ² 2,195 / p <1e-300 | 20.3 EB05 17.4 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 17.0 | no trial data cached |
| Flushing | 175 | 19.3 16.8–22.2ROR 21.2 · χ² 3,028 / p <1e-300 | 19.2 EB05 17.0 · IC025 +3.9 3/3 methods agree | No label text to screen | serious PRR 23.9 | no trial data cached |
| Cardio-respiratory arrest | 72 | 19.3 15.4–24.2ROR 20.0 · χ² 1,229 / p 2e-269 | 19.1 EB05 15.7 · IC025 +3.7 3/3 methods agree | No label text to screen | serious PRR 15.9 | no trial data cached |
| Hyperhidrosis (excessive sweating) | 217 | 19.0 16.7–21.5ROR 21.3 · χ² 3,688 / p <1e-300 | 18.9 EB05 16.9 · IC025 +4.0 3/3 methods agree | No label text to screen | serious PRR 17.0 | no trial data cached |
| Oxygen saturation decreased | 87 | 17.6 14.3–21.6ROR 18.4 · χ² 1,343 / p 3e-294 | 17.5 EB05 14.6 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 14.8 | no trial data cached |
| Ventricular fibrillation | 17 | 17.2 10.7–27.6ROR 17.3 · χ² 243 / p 4e-55 | 16.6 EB05 10.5 · IC025 +2.7 3/3 methods agree | No label text to screen | serious PRR 14.2 | no trial data cached |
| Cardiac arrest (heart stopping) | 108 | 14.7 12.2–17.6ROR 15.5 · χ² 1,366 / p 3e-299 | 14.6 EB05 12.4 · IC025 +3.5 3/3 methods agree | No label text to screen | serious PRR 11.9 | no trial data cached |
| Retching | 26 | 13.8 9.4–20.2ROR 13.9 · χ² 295 / p 2e-66 | 13.3 EB05 9.2 · IC025 +2.8 3/3 methods agree | No label text to screen | serious PRR 18.9 | no trial data cached |
| Heart rate decreased | 42 | 13.4 9.9–18.1ROR 13.7 · χ² 470 / p 2e-104 | 13.1 EB05 10.0 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 12.1 | no trial data cached |
| Respiratory distress | 30 | 12.2 8.6–17.4ROR 12.4 · χ² 298 / p 4e-67 | 11.7 EB05 8.3 · IC025 +2.8 3/3 methods agree | No label text to screen | serious PRR 9.9 | no trial data cached |
| Pharyngeal swelling | 10 | 11.8 6.3–21.8ROR 11.8 · χ² 88 / p 3e-21 | 9.7 EB05 5.0 · IC025 +1.9 3/3 methods agree | No label text to screen | serious n=7 | no trial data cached |
| Paraesthesia oral | 15 | 11.7 7.1–19.4ROR 11.8 · χ² 137 / p 7e-32 | 10.5 EB05 6.2 · IC025 +2.3 3/3 methods agree | No label text to screen | serious PRR 10.4 | no trial data cached |
| Bradycardia (slow heart rate) | 52 | 11.0 8.4–14.4ROR 11.3 · χ² 464 / p 3e-103 | 10.7 EB05 8.3 · IC025 +2.9 3/3 methods agree | No label text to screen | serious PRR 9.2 | no trial data cached |
| Cold sweat | 16 | 10.2 6.3–16.6ROR 10.3 · χ² 124 / p 5e-29 | 8.9 EB05 5.5 · IC025 +2.2 3/3 methods agree | No label text to screen | serious PRR 11.1 | no trial data cached |
| Ventricular tachycardia | 15 | 10.2 6.2–16.9ROR 10.3 · χ² 115 / p 4e-27 | 8.8 EB05 5.3 · IC025 +2.1 3/3 methods agree | No label text to screen | serious PRR 7.9 | no trial data cached |
| Throat tightness | 24 | 10.0 6.7–14.9ROR 10.1 · χ² 186 / p 2e-42 | 9.1 EB05 6.2 · IC025 +2.4 3/3 methods agree | No label text to screen | serious PRR 7.9 | no trial data cached |
| Tachypnoea | 12 | 10.0 5.7–17.5ROR 10.0 · χ² 88 / p 3e-21 | 8.2 EB05 4.7 · IC025 +1.9 3/3 methods agree | No label text to screen | serious PRR 8.5 | no trial data cached |
| Hypotension (low blood pressure) | 161 | 9.0 7.8–10.5ROR 9.8 · χ² 1,154 / p 3e-253 | 8.9 EB05 7.8 · IC025 +2.9 3/3 methods agree | No label text to screen | serious PRR 7.9 | no trial data cached |
| Hypoxia (low oxygen) | 28 | 9.0 6.2–13.0ROR 9.1 · χ² 191 / p 1e-43 | 8.2 EB05 5.8 · IC025 +2.3 3/3 methods agree | No label text to screen | serious PRR 7.5 | no trial data cached |
| Cardiogenic shock | 11 | 8.7 4.8–15.6ROR 8.7 · χ² 67 / p 1e-16 | 6.9 EB05 3.9 · IC025 +1.7 3/3 methods agree | No label text to screen | serious PRR 7.1 | no trial data cached |
| Respiratory arrest | 21 | 8.5 5.6–13.0ROR 8.6 · χ² 132 / p 9e-31 | 7.5 EB05 5.1 · IC025 +2.1 3/3 methods agree | No label text to screen | serious PRR 7.0 | no trial data cached |
| Paraesthesia (tingling/numbness) | 112 | 8.0 6.7–9.6ROR 8.4 · χ² 683 / p 9e-151 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree | No label text to screen | serious PRR 8.0 | no trial data cached |
| Urinary incontinence | 21 | 8.0 5.2–12.2ROR 8.1 · χ² 121 / p 2e-28 | 7.0 EB05 4.8 · IC025 +2.0 3/3 methods agree | No label text to screen | serious PRR 8.8 | no trial data cached |
| Heart rate increased | 70 | 8.0 6.3–10.0ROR 8.2 · χ² 420 / p 1e-93 | 7.7 EB05 6.2 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 5.7 | no trial data cached |
| Sinus tachycardia | 10 | 7.9 4.3–14.7ROR 8.0 · χ² 54 / p 1e-13 | 6.2 EB05 3.5 · IC025 +1.5 3/3 methods agree | No label text to screen | serious PRR 6.0 | no trial data cached |
| Hypersensitivity (allergic reaction) | 128 | 7.8 6.6–9.2ROR 8.3 · χ² 754 / p 2e-166 | 7.6 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen | serious PRR 9.7 | no trial data cached |
| Hypoaesthesia oral | 10 | 7.5 4.0–13.9ROR 7.5 · χ² 50 / p 9e-13 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | No label text to screen | serious PRR 6.8 | no trial data cached |
| Loss of consciousness | 85 | 7.5 6.1–9.2ROR 7.8 · χ² 471 / p 8e-105 | 7.2 EB05 6.0 · IC025 +2.5 3/3 methods agree | No label text to screen | serious PRR 6.4 | no trial data cached |
| Seizure | 70 | 6.9 5.5–8.6ROR 7.1 · χ² 346 / p 1e-77 | 6.6 EB05 5.4 · IC025 +2.3 3/3 methods agree | No label text to screen | serious PRR 5.9 | no trial data cached |
| Erythema (skin redness) | 123 | 6.7 5.7–8.0ROR 7.1 · χ² 601 / p 5e-133 | 6.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | No label text to screen | serious PRR 7.2 | no trial data cached |
| Chest pain | 103 | 6.2 5.2–7.5ROR 6.5 · χ² 452 / p 1e-100 | 6.1 EB05 5.2 · IC025 +2.3 3/3 methods agree | No label text to screen | serious PRR 4.2 | no trial data cached |
| Dyspnoea (shortness of breath) | 312 | 6.2 5.6–6.9ROR 7.3 · χ² 1,394 / p <1e-300 | 6.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | No label text to screen | serious PRR 4.7 | no trial data cached |
| Acute myocardial infarction | 16 | 6.1 3.7–9.9ROR 6.1 · χ² 63 / p 1e-15 | 5.2 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen | serious PRR 5.0 | 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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 312 | 6.2 5.6–6.9ROR 7.3 · χ² 1,394 / p <1e-300 | 6.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | No label text to screen | serious PRR 4.7 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 243 | 50.0 44.4–56.2ROR 57.3 · χ² 11,588 / p <1e-300 | 49.6 EB05 44.5 · IC025 +5.3 3/3 methods agree | No label text to screen | serious PRR 41.4 | no trial data cached |
| Hyperhidrosis (excessive sweating) | 217 | 19.0 16.7–21.5ROR 21.3 · χ² 3,688 / p <1e-300 | 18.9 EB05 16.9 · IC025 +4.0 3/3 methods agree | No label text to screen | serious PRR 17.0 | no trial data cached |
| Flushing | 175 | 19.3 16.8–22.2ROR 21.2 · χ² 3,028 / p <1e-300 | 19.2 EB05 17.0 · IC025 +3.9 3/3 methods agree | No label text to screen | serious PRR 23.9 | no trial data cached |
| Hypotension (low blood pressure) | 161 | 9.0 7.8–10.5ROR 9.8 · χ² 1,154 / p 3e-253 | 8.9 EB05 7.8 · IC025 +2.9 3/3 methods agree | No label text to screen | serious PRR 7.9 | no trial data cached |
| Feeling hot | 136 | 25.0 21.2–29.4ROR 26.9 · χ² 3,107 / p <1e-300 | 24.8 EB05 21.5 · IC025 +4.2 3/3 methods agree | No label text to screen | serious PRR 24.7 | no trial data cached |
| Hypersensitivity (allergic reaction) | 128 | 7.8 6.6–9.2ROR 8.3 · χ² 754 / p 2e-166 | 7.6 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen | serious PRR 9.7 | no trial data cached |
| Erythema (skin redness) | 123 | 6.7 5.7–8.0ROR 7.1 · χ² 601 / p 5e-133 | 6.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | No label text to screen | serious PRR 7.2 | no trial data cached |
| Blood pressure decreased | 120 | 20.4 17.1–24.2ROR 21.7 · χ² 2,195 / p <1e-300 | 20.3 EB05 17.4 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 17.0 | no trial data cached |
| Unresponsive to stimuli | 119 | 52.2 43.9–62.2ROR 55.7 · χ² 5,910 / p <1e-300 | 51.6 EB05 44.3 · IC025 +5.1 3/3 methods agree | No label text to screen | serious PRR 43.8 | no trial data cached |
| Paraesthesia (tingling/numbness) | 112 | 8.0 6.7–9.6ROR 8.4 · χ² 683 / p 9e-151 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree | No label text to screen | serious PRR 8.0 | no trial data cached |
| Cardiac arrest (heart stopping) | 108 | 14.7 12.2–17.6ROR 15.5 · χ² 1,366 / p 3e-299 | 14.6 EB05 12.4 · IC025 +3.5 3/3 methods agree | No label text to screen | serious PRR 11.9 | no trial data cached |
| Chest pain | 103 | 6.2 5.2–7.5ROR 6.5 · χ² 452 / p 1e-100 | 6.1 EB05 5.2 · IC025 +2.3 3/3 methods agree | No label text to screen | serious PRR 4.2 | no trial data cached |
| Oxygen saturation decreased | 87 | 17.6 14.3–21.6ROR 18.4 · χ² 1,343 / p 3e-294 | 17.5 EB05 14.6 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 14.8 | no trial data cached |
| Loss of consciousness | 85 | 7.5 6.1–9.2ROR 7.8 · χ² 471 / p 8e-105 | 7.2 EB05 6.0 · IC025 +2.5 3/3 methods agree | No label text to screen | serious PRR 6.4 | 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 Sulfur Hexafluoride?
In FDA FAERS, the most frequently co-reported reaction terms for Sulfur Hexafluoride are dyspnoea, anaphylactic reaction, hyperhidrosis, flushing, hypotension, feeling hot. 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 Sulfur Hexafluoride 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 Sulfur Hexafluoride 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, 49 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.