Drug · FAERS side-effect profile with label screen
1168 Burn Spray side effects: what 3,072 FDA adverse event reports show
Drug class
Not stated in label
Brand names
1168
openFDA label
Who reports
3,072 reports · 76% serious · 274 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
(s) For the temporary relief of pain associated with minor burns
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 7Lab value / disease marker 10No label text to screen 23
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. 206 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 |
|---|---|---|---|---|---|---|
| Pharmaceutical product complaint | 82 | 21.3 17.2–26.4ROR 21.9 · χ² 1,566 / p <1e-300 | 21.2 EB05 17.6 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.9 | no trial data cached |
| Drug toxicity | 39 | 19.3 14.2–26.4ROR 19.6 · χ² 659 / p 1e-145 | 19.1 EB05 14.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.1 · 97% clinician | no trial data cached |
| Anorexia | 35 | 18.3 13.2–25.5ROR 18.5 · χ² 555 / p 4e-123 | 18.1 EB05 13.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 | no trial data cached |
| Economic problem | 27 | 12.0 8.2–17.5ROR 12.1 · χ² 261 / p 6e-59 | 11.4 EB05 7.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 | no trial data cached |
| Mitral valve incompetence | 17 | 10.3 6.4–16.5ROR 10.3 · χ² 133 / p 4e-31 | 9.0 EB05 5.6 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 | no trial data cached |
| Renal failure acute | 58 | 9.2 7.1–11.9ROR 9.4 · χ² 417 / p 5e-93 | 8.8 EB05 7.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 · 97% clinician | no trial data cached |
| Grand mal convulsion | 12 | 8.8 5.0–15.4ROR 8.8 · χ² 75 / p 3e-18 | 7.1 EB05 4.1 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 | no trial data cached |
| Dialysis | 18 | 8.7 5.5–13.7ROR 8.7 · χ² 114 / p 6e-27 | 7.5 EB05 4.9 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 | no trial data cached |
| Convulsion (seizure) | 69 | 8.1 6.4–10.3ROR 8.3 · χ² 425 / p 8e-95 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 | no trial data cached |
| International normalised ratio increased | 34 | 8.1 5.8–11.3ROR 8.2 · χ² 204 / p 2e-46 | 7.5 EB05 5.5 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 · ♀ 31% (drug 56%) · 100% clinician | no trial data cached |
| Breast cancer female | 31 | 7.9 5.6–11.2ROR 8.0 · χ² 179 / p 3e-41 | 7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 · ♀ 100% (drug 56%) | no trial data cached |
| Mental status changes | 32 | 7.9 5.6–11.1ROR 7.9 · χ² 185 / p 2e-42 | 7.2 EB05 5.3 · IC025 +2.2 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 |
| Blood urea increased | 19 | 7.7 4.9–12.1ROR 7.8 · χ² 104 / p 8e-25 | 6.7 EB05 4.5 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 6.1 | no trial data cached |
| Cardiomegaly | 14 | 7.7 4.6–13.0ROR 7.7 · χ² 75 / p 2e-18 | 6.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 | no trial data cached |
| Atelectasis | 10 | 7.1 3.8–13.1ROR 7.1 · χ² 46 / p 6e-12 | 5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Blood glucose decreased | 47 | 6.7 5.0–8.9ROR 6.8 · χ² 221 / p 3e-50 | 6.3 EB05 4.9 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 2.7 · ♀ 79% (drug 56%) · 91% consumer | no trial data cached |
| Anosmia (loss of smell) | 14 | 6.6 3.9–11.1ROR 6.6 · χ² 61 / p 3e-15 | 5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | no trial data cached |
| Haematocrit decreased | 19 | 6.5 4.2–10.2ROR 6.5 · χ² 83 / p 4e-20 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.6 | no trial data cached |
| Caesarean section | 11 | 6.4 3.5–11.5ROR 6.4 · χ² 45 / p 1e-11 | 5.2 EB05 3.1 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Multi-organ failure | 16 | 6.2 3.8–10.2ROR 6.3 · χ² 65 / p 3e-16 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Ventricular tachycardia | 15 | 6.2 3.7–10.3ROR 6.2 · χ² 60 / p 4e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Drug exposure during pregnancy | 31 | 6.1 4.3–8.7ROR 6.2 · χ² 129 / p 4e-30 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 · ♀ 89% (drug 56%) | no trial data cached |
| Post procedural complication | 17 | 6.0 3.8–9.7ROR 6.1 · χ² 67 / p 2e-16 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Sinus tachycardia | 12 | 5.8 3.3–10.2ROR 5.8 · χ² 43 / p 3e-11 | 4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | no trial data cached |
| Pregnancy | 17 | 5.7 3.6–9.2ROR 5.8 · χ² 62 / p 2e-15 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 | no trial data cached |
| Cardiomyopathy | 12 | 5.5 3.2–9.8ROR 5.6 · χ² 40 / p 1e-10 | 4.6 EB05 2.8 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| No therapeutic response | 10 | 5.5 3.0–10.3ROR 5.5 · χ² 33 / p 5e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | no trial data cached |
| Liver function test abnormal | 23 | 5.4 3.6–8.1ROR 5.4 · χ² 78 / p 6e-19 | 4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 · ♀ 35% (drug 56%) | no trial data cached |
| Aspartate aminotransferase increased | 41 | 5.3 3.9–7.2ROR 5.3 · χ² 138 / p 3e-32 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 3.9 · 100% clinician | no trial data cached |
| Drug effect decreased | 42 | 5.3 3.9–7.1ROR 5.3 · χ² 141 / p 9e-33 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 | no trial data cached |
| Blood glucose increased | 144 | 5.2 4.4–6.1ROR 5.4 · χ² 489 / p 1e-108 | 5.1 EB05 4.5 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 2.3 · 82% consumer | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 31 | 5.1 3.6–7.2ROR 5.1 · χ² 98 / p 2e-23 | 4.7 EB05 3.5 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 · 100% clinician | no trial data cached |
| Medication error | 41 | 5.0 3.7–6.8ROR 5.1 · χ² 129 / p 3e-30 | 4.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 | no trial data cached |
| Disseminated intravascular coagulation | 10 | 4.8 2.6–9.0ROR 4.9 · χ² 27 / p 1e-7 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | no trial data cached |
| Ejection fraction decreased | 11 | 4.8 2.7–8.7ROR 4.8 · χ² 30 / p 3e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 3.7 | no trial data cached |
| Blood lactate dehydrogenase increased | 11 | 4.7 2.6–8.5ROR 4.7 · χ² 29 / p 4e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 3.5 | no trial data cached |
| Hyperkalaemia (high potassium) | 24 | 4.7 3.2–7.0ROR 4.7 · χ² 66 / p 2e-16 | 4.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | no trial data cached |
| Blood creatine phosphokinase increased | 20 | 4.7 3.0–7.2ROR 4.7 · χ² 54 / p 9e-14 | 4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 4.0 · ♀ 35% (drug 56%) | no trial data cached |
| Eructation (belching) | 13 | 4.7 2.7–8.0ROR 4.7 · χ² 34 / p 3e-9 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Blood alkaline phosphatase increased | 17 | 4.7 2.9–7.5ROR 4.7 · χ² 45 / p 8e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 3.6 | 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 |
|---|---|---|---|---|---|---|
| Weight decreased (weight loss) | 177 | 4.3 3.8–5.0ROR 4.5 · χ² 457 / p 1e-101 | 4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.7 · 79% consumer | no trial data cached |
| Blood glucose increased | 144 | 5.2 4.4–6.1ROR 5.4 · χ² 489 / p 1e-108 | 5.1 EB05 4.5 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 2.3 · 82% consumer | no trial data cached |
| Pharmaceutical product complaint | 82 | 21.3 17.2–26.4ROR 21.9 · χ² 1,566 / p <1e-300 | 21.2 EB05 17.6 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.9 | no trial data cached |
| Dehydration | 72 | 3.7 2.9–4.6ROR 3.8 · χ² 139 / p 2e-32 | 3.6 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | no trial data cached |
| Convulsion (seizure) | 69 | 8.1 6.4–10.3ROR 8.3 · χ² 425 / p 8e-95 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 | no trial data cached |
| Renal failure acute | 58 | 9.2 7.1–11.9ROR 9.4 · χ² 417 / p 5e-93 | 8.8 EB05 7.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 · 97% clinician | no trial data cached |
| Hyperhidrosis (excessive sweating) | 57 | 3.0 2.3–3.9ROR 3.1 · χ² 75 / p 2e-18 | 3.0 EB05 2.4 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | no trial data cached |
| Loss of consciousness | 57 | 3.0 2.3–3.9ROR 3.1 · χ² 76 / p 1e-18 | 3.0 EB05 2.4 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | no trial data cached |
| Atrial fibrillation | 51 | 3.6 2.7–4.7ROR 3.6 · χ² 92 / p 4e-22 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | no trial data cached |
| Haemoglobin decreased | 47 | 3.1 2.4–4.1ROR 3.2 · χ² 66 / p 2e-16 | 3.0 EB05 2.4 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 2.6 | no trial data cached |
| Blood glucose decreased | 47 | 6.7 5.0–8.9ROR 6.8 · χ² 221 / p 3e-50 | 6.3 EB05 4.9 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 2.7 · ♀ 79% (drug 56%) · 91% consumer | no trial data cached |
| Myocardial infarction (heart attack) | 44 | 1.7 1.3–2.3ROR 1.7 · χ² 12 / p 2e-4 | 1.7 EB05 1.3 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 1.3 | no trial data cached |
| Drug effect decreased | 42 | 5.3 3.9–7.1ROR 5.3 · χ² 141 / p 9e-33 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 | no trial data cached |
| Medication error | 41 | 5.0 3.7–6.8ROR 5.1 · χ² 129 / p 3e-30 | 4.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 | no trial data cached |
| Aspartate aminotransferase increased | 41 | 5.3 3.9–7.2ROR 5.3 · χ² 138 / p 3e-32 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 3.9 · 100% clinician | 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 1168 Burn Spray?
In FDA FAERS, the most frequently co-reported reaction terms for 1168 Burn Spray are weight decreased, blood glucose increased, pharmaceutical product complaint, dehydration, convulsion, renal failure acute. 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 1168 Burn Spray have an FDA boxed warning?
No. The FDA label retrieved for 1168 Burn Spray has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that 1168 Burn Spray 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 1183a4f5-f875-dfb0-e063-6394a90af35f, effective 20240216; matched on
openfda.generic_name.exact:"1168 BURN SPRAY") - 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, 246 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.