Drug · FAERS side-effect profile with label screen
Xylometazoline side effects: what 539 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Xylometazoline Hydrochloride (Metarivin Soln. 0.1%)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
539 reports · 78% serious · 80 with death outcome · 57% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Adults and children 7 years and older: Spray into the nose 3 times a day
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 22 strongest signals
Reporting / coding artifact 4Lab value / disease marker 1No label text to screen 17
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. 8 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 |
|---|---|---|---|---|---|---|
| Appendicitis | 38 | 159.4 117.2–216.7ROR 171.4 · χ² 5,802 / p <1e-300 | 147.1 EB05 111.9 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 118.9 · ♀ 3% (drug 57%) · 97% clinician | no trial data cached |
| Ventricular fibrillation | 35 | 122.4 88.8–168.7ROR 130.8 · χ² 4,083 / p <1e-300 | 114.5 EB05 86.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 90.3 · ♀ 0% (drug 57%) · 97% clinician | no trial data cached |
| Cardiogenic shock | 36 | 98.2 71.6–134.7ROR 105.1 · χ² 3,361 / p <1e-300 | 93.2 EB05 70.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 72.2 · ♀ 3% (drug 57%) · 97% clinician | no trial data cached |
| Incorrect route of product administration | 25 | 57.8 39.4–84.9ROR 60.6 · χ² 1,339 / p 2e-293 | 55.5 EB05 39.5 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 85.2 · ♀ 0% (drug 57%) · 96% clinician | no trial data cached |
| Ascites | 43 | 56.8 42.7–75.7ROR 61.7 · χ² 2,303 / p <1e-300 | 55.4 EB05 42.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.5 · ♀ 5% (drug 57%) · 98% clinician | no trial data cached |
| Bacterial infection | 27 | 56.5 39.1–81.7ROR 59.5 · χ² 1,417 / p <1e-300 | 54.4 EB05 39.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.2 · ♀ 4% (drug 57%) | no trial data cached |
| Multiple organ dysfunction syndrome | 38 | 52.9 39.0–72.0ROR 56.9 · χ² 1,885 / p <1e-300 | 51.6 EB05 39.2 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.0 · ♀ 0% (drug 57%) · 97% clinician | no trial data cached |
| Neuralgia | 26 | 41.7 28.6–60.6ROR 43.7 · χ² 992 / p 5e-218 | 40.5 EB05 29.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.9 · ♀ 8% (drug 57%) · 92% clinician | no trial data cached |
| Hyperlipidaemia | 12 | 38.9 22.2–68.1ROR 39.8 · χ² 406 / p 1e-90 | 36.8 EB05 22.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.6 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 15 | 38.7 23.5–63.7ROR 39.7 · χ² 513 / p 7e-114 | 37.0 EB05 23.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.5 | no trial data cached |
| Gout | 13 | 28.1 16.4–48.1ROR 28.8 · χ² 313 / p 2e-70 | 27.1 EB05 16.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.4 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 16 | 27.9 17.2–45.2ROR 28.7 · χ² 389 / p 8e-87 | 27.1 EB05 17.6 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.8 | no trial data cached |
| Hyponatraemia (low sodium) | 40 | 27.7 20.5–37.3ROR 29.8 · χ² 1,003 / p 2e-220 | 27.3 EB05 20.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.9 · ♀ 0% (drug 57%) · 98% clinician | no trial data cached |
| Ulcer | 11 | 26.8 14.9–48.2ROR 27.4 · χ² 248 / p 3e-56 | 25.6 EB05 15.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.0 | no trial data cached |
| Stress | 46 | 24.8 18.8–32.8ROR 27.1 · χ² 1,032 / p 9e-227 | 24.6 EB05 19.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.8 · ♀ 8% (drug 57%) | no trial data cached |
| Hernia | 11 | 22.2 12.4–39.9ROR 22.6 · χ² 202 / p 4e-46 | 21.2 EB05 12.1 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.4 | no trial data cached |
| Gastric ulcer | 10 | 20.4 11.0–37.7ROR 20.8 · χ² 166 / p 3e-38 | 19.2 EB05 10.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.9 | no trial data cached |
| Blood cholesterol increased | 24 | 20.0 13.5–29.6ROR 20.9 · χ² 415 / p 2e-92 | 19.7 EB05 13.8 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 22.4 · ♀ 4% (drug 57%) · 96% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 24 | 17.9 12.1–26.4ROR 18.7 · χ² 367 / p 5e-82 | 17.5 EB05 12.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.4 · ♀ 8% (drug 57%) · 92% clinician | no trial data cached |
| Intentional product misuse | 26 | 11.6 8.0–16.9ROR 12.2 · χ² 243 / p 4e-55 | 11.0 EB05 7.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 18.7 · ♀ 0% (drug 57%) | no trial data cached |
| Foetal exposure during pregnancy | 18 | 8.6 5.5–13.6ROR 8.9 · χ² 114 / p 7e-27 | 7.5 EB05 4.8 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 | no trial data cached |
| Drug dependence | 34 | 8.1 5.9–11.2ROR 8.6 · χ² 207 / p 4e-47 | 7.5 EB05 5.6 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · ♀ 27% (drug 57%) · 97% consumer | 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 |
|---|---|---|---|---|---|---|
| Stress | 46 | 24.8 18.8–32.8ROR 27.1 · χ² 1,032 / p 9e-227 | 24.6 EB05 19.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.8 · ♀ 8% (drug 57%) | no trial data cached |
| Ascites | 43 | 56.8 42.7–75.7ROR 61.7 · χ² 2,303 / p <1e-300 | 55.4 EB05 42.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.5 · ♀ 5% (drug 57%) · 98% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 40 | 27.7 20.5–37.3ROR 29.8 · χ² 1,003 / p 2e-220 | 27.3 EB05 20.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.9 · ♀ 0% (drug 57%) · 98% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 38 | 52.9 39.0–72.0ROR 56.9 · χ² 1,885 / p <1e-300 | 51.6 EB05 39.2 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.0 · ♀ 0% (drug 57%) · 97% clinician | no trial data cached |
| Appendicitis | 38 | 159.4 117.2–216.7ROR 171.4 · χ² 5,802 / p <1e-300 | 147.1 EB05 111.9 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 118.9 · ♀ 3% (drug 57%) · 97% clinician | no trial data cached |
| Cardiogenic shock | 36 | 98.2 71.6–134.7ROR 105.1 · χ² 3,361 / p <1e-300 | 93.2 EB05 70.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 72.2 · ♀ 3% (drug 57%) · 97% clinician | no trial data cached |
| Ventricular fibrillation | 35 | 122.4 88.8–168.7ROR 130.8 · χ² 4,083 / p <1e-300 | 114.5 EB05 86.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 90.3 · ♀ 0% (drug 57%) · 97% clinician | no trial data cached |
| Drug dependence | 34 | 8.1 5.9–11.2ROR 8.6 · χ² 207 / p 4e-47 | 7.5 EB05 5.6 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · ♀ 27% (drug 57%) · 97% consumer | no trial data cached |
| Bacterial infection | 27 | 56.5 39.1–81.7ROR 59.5 · χ² 1,417 / p <1e-300 | 54.4 EB05 39.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.2 · ♀ 4% (drug 57%) | no trial data cached |
| Intentional product misuse | 26 | 11.6 8.0–16.9ROR 12.2 · χ² 243 / p 4e-55 | 11.0 EB05 7.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 18.7 · ♀ 0% (drug 57%) | no trial data cached |
| Neuralgia | 26 | 41.7 28.6–60.6ROR 43.7 · χ² 992 / p 5e-218 | 40.5 EB05 29.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.9 · ♀ 8% (drug 57%) · 92% clinician | no trial data cached |
| Incorrect route of product administration | 25 | 57.8 39.4–84.9ROR 60.6 · χ² 1,339 / p 2e-293 | 55.5 EB05 39.5 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 85.2 · ♀ 0% (drug 57%) · 96% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 24 | 17.9 12.1–26.4ROR 18.7 · χ² 367 / p 5e-82 | 17.5 EB05 12.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.4 · ♀ 8% (drug 57%) · 92% clinician | no trial data cached |
| Blood cholesterol increased | 24 | 20.0 13.5–29.6ROR 20.9 · χ² 415 / p 2e-92 | 19.7 EB05 13.8 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 22.4 · ♀ 4% (drug 57%) · 96% clinician | no trial data cached |
| Foetal exposure during pregnancy | 18 | 8.6 5.5–13.6ROR 8.9 · χ² 114 / p 7e-27 | 7.5 EB05 4.8 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 | 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 Xylometazoline?
In FDA FAERS, the most frequently co-reported reaction terms for Xylometazoline are stress, ascites, hyponatraemia, multiple organ dysfunction syndrome, appendicitis, cardiogenic shock. 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 Xylometazoline have an FDA boxed warning?
No. The FDA label retrieved for Xylometazoline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Xylometazoline 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 e9da6f39-8620-faca-e053-2995a90a8a57, effective 20220930; matched on
openfda.generic_name.exact:"XYLOMETAZOLINE HYDROCHLORIDE") - 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, 30 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.