Drug · FAERS side-effect profile with label screen
Burn Relief side effects: what 48,628 FDA adverse event reports show
Drug class
Amide Local Anesthetic, Antiarrhythmic
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Lidocaine
openFDA label
Who reports
48,628 reports · 73% serious · 4,963 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
for temporary relief of pain and itching associated with: sunburn minor burns minor cuts insect bites scrapes minor skin irritations
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 8No label text to screen 32
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.
- 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). 1,153 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 |
|---|---|---|---|---|---|---|
| Local anaesthetic systemic toxicity | 607 | 619.2 546.7–701.2ROR 627.0 · calibrated p 6e-15 ✓ | 250.4 EB05 234.1 · IC025 +7.6 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.1 (3.7–4.4) | No label text to screen label has no adverse-reaction text | serious n=604 · 100% clinician | no trial arm names this drug |
| Inspiratory capacity decreased | 84 | 189.6 146.6–245.2ROR 189.9 · calibrated p 1e-9 ✓ | 127.6 EB05 106.3 · IC025 +5.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.0 (3.1–5.0) | No label text to screen label has no adverse-reaction text | serious n=84 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Sleep disorder therapy | 55 | 180.9 132.0–248.0ROR 181.1 · calibrated p 2e-9 ✓ | 121.9 EB05 97.1 · IC025 +5.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.4 (3.3–5.9) | Reporting / coding artifact | serious n=55 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Appendicolith | 81 | 116.9 91.4–149.5ROR 117.1 · calibrated p 5e-8 ✓ | 90.0 EB05 74.7 · IC025 +5.5 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.4 (3.4–5.6) | No label text to screen label has no adverse-reaction text | serious n=81 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Analgesic therapy | 55 | 94.1 70.3–126.0ROR 94.2 · calibrated p 3e-7 ✓ | 75.3 EB05 60.0 · IC025 +5.1 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.4 (3.3–5.9) | Reporting / coding artifact | serious n=55 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Drug therapy | 55 | 89.4 66.9–119.6ROR 89.5 · calibrated p 4e-7 ✓ | 72.2 EB05 57.6 · IC025 +5.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.4 (3.3–5.9) | Reporting / coding artifact | serious n=55 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Maternal exposure during delivery | 153 | 80.6 67.8–95.7ROR 80.8 · calibrated p 6e-7 ✓ | 67.3 EB05 58.8 · IC025 +5.5 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.1 (2.6–3.7) | Reporting / coding artifact | serious n=142 · ♀ 100% (drug 63%) · 100% clinician | no trial arm names this drug |
| Toxic anterior segment syndrome | 168 | 78.6 66.7–92.6ROR 78.9 · calibrated p 7e-7 ✓ | 66.0 EB05 58.0 · IC025 +5.5 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.3 (3.6–5.1) | No label text to screen label has no adverse-reaction text | serious n=163 | no trial arm names this drug |
| Infusion site discharge | 217 | 62.6 54.3–72.2ROR 62.9 · calibrated p 3e-6 ✓ | 54.4 EB05 48.6 · IC025 +5.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.6 (3.2–4.2) | No label text to screen label has no adverse-reaction text | serious n=186 · ♀ 84% (drug 63%) · 88% consumer | no trial arm names this drug |
| Methaemoglobinaemia | 244 | 51.1 44.7–58.3ROR 51.3 · calibrated p 1e-5 ✓ | 45.5 EB05 41.0 · IC025 +5.2 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.3 (3.7–4.9) | No label text to screen label has no adverse-reaction text | serious n=233 · ♀ 41% (drug 63%) · 100% clinician | no trial arm names this drug |
| Lagophthalmos | 43 | 50.4 36.7–69.1ROR 50.5 · calibrated p 2e-5 ✓ | 44.3 EB05 34.3 · IC025 +4.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.9 (3.5–6.9) | No label text to screen label has no adverse-reaction text | serious n=41 · 100% clinician | no trial arm names this drug |
| Infusion site mass | 95 | 42.0 34.1–51.9ROR 42.1 · calibrated p 5e-5 ✓ | 38.1 EB05 32.1 · IC025 +4.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.6 (2.9–4.5) | No label text to screen label has no adverse-reaction text | serious n=77 · ♀ 85% (drug 63%) · 72% consumer | no trial arm names this drug |
| Infusion site urticaria | 58 | 41.6 31.8–54.4ROR 41.6 · calibrated p 6e-5 ✓ | 37.5 EB05 30.1 · IC025 +4.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.1 (3.1–5.4) | No label text to screen label has no adverse-reaction text | serious n=47 · ♀ 100% (drug 63%) | no trial arm names this drug |
| Infusion site bruising | 176 | 38.8 33.3–45.3ROR 39.0 · calibrated p 7e-5 ✓ | 35.5 EB05 31.3 · IC025 +4.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.9 (3.3–4.5) | No label text to screen label has no adverse-reaction text | serious n=138 | no trial arm names this drug |
| Infusion site pruritus | 252 | 37.9 33.3–43.0ROR 38.0 · calibrated p 7e-5 ✓ | 34.8 EB05 31.3 · IC025 +4.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.8 (3.3–4.4) | No label text to screen label has no adverse-reaction text | serious n=180 · ♀ 88% (drug 63%) | no trial arm names this drug |
| Infusion site haemorrhage | 238 | 34.1 29.9–38.9ROR 34.3 · calibrated p 1e-4 ✓ | 31.6 EB05 28.3 · IC025 +4.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.4 (3.0–3.9) | No label text to screen label has no adverse-reaction text | serious n=189 · 75% consumer | no trial arm names this drug |
| Cauda equina syndrome | 49 | 29.1 21.8–38.9ROR 29.2 · calibrated p 4e-4 ✓ | 27.1 EB05 21.3 · IC025 +4.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.4 (2.5–4.7) | No label text to screen label has no adverse-reaction text | serious n=49 · 100% clinician | no trial arm names this drug |
| Procedural hypotension | 52 | 27.8 21.0–36.8ROR 27.8 · calibrated p 5e-4 ✓ | 25.9 EB05 20.5 · IC025 +3.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.7 (2.8–5.0) | No label text to screen label has no adverse-reaction text | serious n=51 · ♀ 100% (drug 63%) · 100% clinician | no trial arm names this drug |
| Infusion site rash | 82 | 27.6 22.0–34.4ROR 27.6 · calibrated p 5e-4 ✓ | 25.8 EB05 21.4 · IC025 +4.1 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.7 (2.9–4.7) | No label text to screen label has no adverse-reaction text | serious n=58 | no trial arm names this drug |
| Infusion site swelling | 367 | 27.3 24.6–30.3ROR 27.5 · calibrated p 4e-4 ✓ | 25.7 EB05 23.5 · IC025 +4.5 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.5 (3.1–3.9) | No label text to screen label has no adverse-reaction text | serious n=251 | no trial arm names this drug |
| Chronic kidney disease-mineral and bone disorder | 62 | 26.3 20.4–34.0ROR 26.3 · calibrated p 6e-4 ✓ | 24.7 EB05 19.9 · IC025 +4.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.5 (3.4–5.9) | No label text to screen label has no adverse-reaction text | serious n=62 | no trial arm names this drug |
| Foetal exposure during delivery | 39 | 26.0 18.8–35.9ROR 26.0 · calibrated p 8e-4 ✓ | 24.3 EB05 18.5 · IC025 +3.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.3 (3.0–6.0) | Reporting / coding artifact | serious n=38 · 100% clinician | no trial arm names this drug |
| Infusion site discomfort | 58 | 25.9 19.9–33.7ROR 25.9 · calibrated p 7e-4 ✓ | 24.3 EB05 19.5 · IC025 +3.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.6 (2.7–4.8) | No label text to screen label has no adverse-reaction text | serious n=48 · ♀ 100% (drug 63%) · 100% consumer | no trial arm names this drug |
| Anaesthetic complication neurological | 50 | 25.0 18.8–33.2ROR 25.0 · calibrated p 9e-4 ✓ | 23.4 EB05 18.5 · IC025 +3.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.8 (2.8–5.2) | No label text to screen label has no adverse-reaction text | serious n=48 · 100% clinician | no trial arm names this drug |
| Infusion site nodule | 49 | 24.8 18.6–33.0ROR 24.8 · calibrated p 9e-4 ✓ | 23.3 EB05 18.3 · IC025 +3.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.3 (2.4–4.4) | No label text to screen label has no adverse-reaction text | ♀ 100% (drug 63%) · 100% consumer | no trial arm names this drug |
| Anaesthetic complication | 143 | 24.3 20.6–28.8ROR 24.4 · calibrated p 8e-4 ✓ | 23.0 EB05 20.0 · IC025 +4.1 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.3 (2.7–3.9) | Reporting / coding artifact | serious n=125 · 100% clinician | no trial arm names this drug |
| Infusion site warmth | 58 | 21.8 16.7–28.4ROR 21.8 · calibrated p 0.002 ✓ | 20.7 EB05 16.6 · IC025 +3.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.3 (2.5–4.3) | No label text to screen label has no adverse-reaction text | serious n=40 · ♀ 100% (drug 63%) · 100% consumer | no trial arm names this drug |
| Kounis syndrome | 108 | 21.6 17.8–26.2ROR 21.6 · calibrated p 0.002 ✓ | 20.5 EB05 17.5 · IC025 +3.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.1 (3.4–5.1) | No label text to screen label has no adverse-reaction text | serious n=108 · 100% clinician | no trial arm names this drug |
| Infusion site irritation | 57 | 20.7 15.8–27.0ROR 20.7 · calibrated p 0.002 ✓ | 19.6 EB05 15.7 · IC025 +3.6 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.0 (2.3–4.0) | No label text to screen label has no adverse-reaction text | serious n=35 · ♀ 100% (drug 63%) · 100% consumer | no trial arm names this drug |
| Infusion site discolouration | 39 | 20.4 14.8–28.1ROR 20.4 · calibrated p 0.002 ✓ | 19.3 EB05 14.7 · IC025 +3.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.1 (2.9–5.8) | No label text to screen label has no adverse-reaction text | ♀ 100% (drug 63%) · 100% consumer | no trial arm names this drug |
| Nephrogenic anaemia | 209 | 20.1 17.5–23.1ROR 20.2 · calibrated p 0.002 ✓ | 19.2 EB05 17.1 · IC025 +4.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.4 (3.8–5.1) | No label text to screen label has no adverse-reaction text | serious n=209 | no trial arm names this drug |
| Hyperparathyroidism secondary | 110 | 19.5 16.1–23.6ROR 19.6 · calibrated p 0.002 ✓ | 18.7 EB05 15.9 · IC025 +3.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.4 (3.6–5.4) | No label text to screen label has no adverse-reaction text | serious n=110 | no trial arm names this drug |
| Infusion site erythema | 357 | 19.4 17.4–21.5ROR 19.5 · calibrated p 0.002 ✓ | 18.5 EB05 17.0 · IC025 +4.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.2 (2.9–3.6) | No label text to screen label has no adverse-reaction text | serious n=239 | no trial arm names this drug |
| Device infusion issue | 105 | 19.3 15.8–23.4ROR 19.3 · calibrated p 0.003 ✓ | 18.4 EB05 15.6 · IC025 +3.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.1 (2.5–3.8) | Reporting / coding artifact | serious n=87 · 100% consumer | no trial arm names this drug |
| Infusion site pain | 538 | 18.9 17.4–20.6ROR 19.1 · calibrated p 0.002 ✓ | 18.1 EB05 16.9 · IC025 +4.0 3/3 methods agree vs other Amide Local Anesthetics: PRR 2.6 (2.3–2.8) | No label text to screen label has no adverse-reaction text | serious n=355 | no trial arm names this drug |
| Incorrect drug administration rate | 176 | 18.7 16.1–21.7ROR 18.7 · calibrated p 0.003 ✓ | 17.9 EB05 15.8 · IC025 +3.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.2 (3.6–5.0) | Reporting / coding artifact | serious n=150 | no trial arm names this drug |
| Hyperphosphataemia | 87 | 18.4 14.9–22.8ROR 18.4 · calibrated p 0.003 ✓ | 17.6 EB05 14.7 · IC025 +3.7 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.3 (3.4–5.5) | No label text to screen label has no adverse-reaction text | serious n=87 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
| Infusion site extravasation | 245 | 17.6 15.5–20.0ROR 17.7 · calibrated p 0.004 ✓ | 17.0 EB05 15.2 · IC025 +3.8 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.2 (3.6–4.8) | No label text to screen label has no adverse-reaction text | serious n=153 | no trial arm names this drug |
| Administration site pain | 43 | 16.9 12.5–23.0ROR 17.0 · calibrated p 0.005 ✓ | 16.2 EB05 12.4 · IC025 +3.3 3/3 methods agree vs other Amide Local Anesthetics: PRR 5.6 (4.0–7.9) | No label text to screen label has no adverse-reaction text | ♀ 100% (drug 63%) | no trial arm names this drug |
| Vasoplegia syndrome | 60 | 16.6 12.8–21.5ROR 16.6 · calibrated p 0.005 ✓ | 15.9 EB05 12.8 · IC025 +3.4 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.2 (3.2–5.6) | No label text to screen label has no adverse-reaction text | serious n=60 · ♀ 0% (drug 63%) · 100% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Burn Relief (searched BURN RELIEF).
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 ineffective (drug did not work) | 3,593 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.434 | 1.2 EB05 1.1 · IC025 +0.2 vs other Amide Local Anesthetics: PRR 3.3 (3.2–3.4) | Reporting / coding artifact | serious PRR 1.7 | no trial arm names this drug |
| Pain | 3,168 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.898 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.6 (3.5–3.7) | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial arm names this drug |
| Fatigue (tiredness) | 3,038 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.790 | 1.7 EB05 1.6 · IC025 +0.7 vs other Amide Local Anesthetics: PRR 3.9 (3.7–4.0) | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial arm names this drug |
| Nausea | 3,029 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.770 | 1.7 EB05 1.6 · IC025 +0.7 vs other Amide Local Anesthetics: PRR 3.7 (3.6–3.9) | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial arm names this drug |
| Headache | 2,802 | 1.9 1.9–2.0ROR 2.0 · calibrated p 0.939 | 1.9 EB05 1.9 · IC025 +0.9 vs other Amide Local Anesthetics: PRR 3.8 (3.7–4.0) | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial arm names this drug |
| Off label use (used outside approved label) | 2,605 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.516 | 1.3 EB05 1.3 · IC025 +0.3 vs other Amide Local Anesthetics: PRR 2.6 (2.5–2.7) | Reporting / coding artifact | serious PRR 1.4 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 2,165 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.759 | 1.6 EB05 1.6 · IC025 +0.7 vs other Amide Local Anesthetics: PRR 3.7 (3.6–3.9) | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | no trial arm names this drug |
| Pneumonia (lung infection) | 2,001 | 2.7 2.6–2.8ROR 2.8 · calibrated p 0.713 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.0 (3.8–4.2) | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 1,966 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.530 | 1.3 EB05 1.3 · IC025 +0.3 vs other Amide Local Anesthetics: PRR 3.7 (3.6–3.9) | No label text to screen label has no adverse-reaction text | serious PRR 1.3 | no trial arm names this drug |
| Sinusitis | 1,939 | 8.3 7.9–8.6ROR 8.6 · calibrated p 0.054 | 8.1 EB05 7.8 · IC025 +2.9 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.1 (3.9–4.3) | No label text to screen label has no adverse-reaction text | serious PRR 8.5 | no trial arm names this drug |
| Vomiting | 1,839 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.782 | 1.7 EB05 1.6 · IC025 +0.7 vs other Amide Local Anesthetics: PRR 3.8 (3.6–3.9) | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | no trial arm names this drug |
| Product dose omission issue | 1,718 | 2.6 2.5–2.7ROR 2.7 · calibrated p 0.744 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Amide Local Anesthetics: PRR 4.0 (3.8–4.2) | Reporting / coding artifact | serious PRR 6.1 | no trial arm names this drug |
| Fall | 1,713 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.916 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Amide Local Anesthetics: PRR 3.9 (3.7–4.1) | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial arm names this drug |
| Dizziness | 1,697 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.634 | 1.5 EB05 1.4 · IC025 +0.5 vs other Amide Local Anesthetics: PRR 3.7 (3.5–3.9) | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | no trial arm names this drug |
| Death | 1,679 | 0.8 0.8–0.9ROR 0.8 · calibrated p 0.204 | 0.8 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC vs other Amide Local Anesthetics: PRR 4.1 (3.9–4.3) | Outcome field, not a reaction | serious PRR 0.7 | no trial arm names this drug |
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 Burn Relief?
In FDA FAERS, the most frequently co-reported reaction terms for Burn Relief are pain, fatigue, nausea, headache, dyspnoea, pneumonia. 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 Burn Relief have an FDA boxed warning?
No. The FDA label retrieved for Burn Relief has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Burn Relief 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 b25dc0df-02d0-41ac-b36c-2c04baa77ef2, effective 20251027; matched on
openfda.generic_name.exact:"BURN RELIEF") - 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, 1,193 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
BURN RELIEF, 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.