Avobenzone side effects: what 258 FDA adverse event reports show
Drug class
No validated FDA label found
Who reports
258 reports · 86% serious · 5 with death outcome · 67% female
Used for
—
Causality screen of the 8 strongest signals
What the badges mean
- 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. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Skin cancer | 58 | 219.4 174.8–275.2ROR 282.7 · χ² 12,368 / p <1e-300 | 204.1 EB05 163.7 · IC025 +5.8 3/3 methods agree | No label text to screen | serious PRR 150.0 · 97% consumer | no trial data cached |
| Malignant melanoma | 19 | 115.3 74.7–177.7ROR 124.3 · χ² 2,038 / p <1e-300 | 103.4 EB05 70.0 · IC025 +4.1 3/3 methods agree | No label text to screen | serious PRR 78.4 | no trial data cached |
| Basal cell carcinoma | 21 | 109.4 72.6–164.9ROR 119.0 · χ² 2,148 / p <1e-300 | 99.6 EB05 68.7 · IC025 +4.2 3/3 methods agree | No label text to screen | serious PRR 75.6 · 100% consumer | no trial data cached |
| Squamous cell carcinoma | 8 | 69.0 34.9–136.6ROR 71.2 · χ² 470 / p 1e-104 | 59.7 EB05 32.4 · IC025 +2.6 3/3 methods agree | No label text to screen | serious PRR 47.8 | no trial data cached |
| Application site rash | 6 | 35.4 16.0–78.0ROR 36.2 · χ² 167 / p 1e-38 | 31.6 EB05 14.9 · IC025 +1.9 3/3 methods agree | No label text to screen | serious n=5 | no trial data cached |
| Neoplasm malignant | 21 | 25.6 17.0–38.6ROR 27.8 · χ² 473 / p 3e-105 | 25.1 EB05 17.3 · IC025 +3.3 3/3 methods agree | No label text to screen | serious PRR 17.6 · 100% consumer | no trial data cached |
| Application site pain | 6 | 22.2 10.0–48.9ROR 22.7 · χ² 101 / p 5e-24 | 19.2 EB05 7.3 · IC025 +1.7 3/3 methods agree | No label text to screen | serious n=3 | no trial data cached |
| Application site erythema | 6 | 18.5 8.4–40.9ROR 19.0 · χ² 83 / p 4e-20 | 15.3 EB05 5.6 · IC025 +1.6 3/3 methods agree | No label text to screen | serious n=3 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Skin cancer | 58 | 219.4 174.8–275.2ROR 282.7 · χ² 12,368 / p <1e-300 | 204.1 EB05 163.7 · IC025 +5.8 3/3 methods agree | No label text to screen | serious PRR 150.0 · 97% consumer | no trial data cached |
| Neoplasm malignant | 21 | 25.6 17.0–38.6ROR 27.8 · χ² 473 / p 3e-105 | 25.1 EB05 17.3 · IC025 +3.3 3/3 methods agree | No label text to screen | serious PRR 17.6 · 100% consumer | no trial data cached |
| Basal cell carcinoma | 21 | 109.4 72.6–164.9ROR 119.0 · χ² 2,148 / p <1e-300 | 99.6 EB05 68.7 · IC025 +4.2 3/3 methods agree | No label text to screen | serious PRR 75.6 · 100% consumer | no trial data cached |
| Malignant melanoma | 19 | 115.3 74.7–177.7ROR 124.3 · χ² 2,038 / p <1e-300 | 103.4 EB05 70.0 · IC025 +4.1 3/3 methods agree | No label text to screen | serious PRR 78.4 | no trial data cached |
| Squamous cell carcinoma | 8 | 69.0 34.9–136.6ROR 71.2 · χ² 470 / p 1e-104 | 59.7 EB05 32.4 · IC025 +2.6 3/3 methods agree | No label text to screen | serious PRR 47.8 | no trial data cached |
| Application site erythema | 6 | 18.5 8.4–40.9ROR 19.0 · χ² 83 / p 4e-20 | 15.3 EB05 5.6 · IC025 +1.6 3/3 methods agree | No label text to screen | serious n=3 | no trial data cached |
| Application site pain | 6 | 22.2 10.0–48.9ROR 22.7 · χ² 101 / p 5e-24 | 19.2 EB05 7.3 · IC025 +1.7 3/3 methods agree | No label text to screen | serious n=3 | no trial data cached |
| Application site rash | 6 | 35.4 16.0–78.0ROR 36.2 · χ² 167 / p 1e-38 | 31.6 EB05 14.9 · IC025 +1.9 3/3 methods agree | No label text to screen | serious n=5 | no trial data cached |
| Acute myeloid leukaemia | 4 | 20.9 7.9–55.2ROR 21.2 · χ² 57 / p 2e-14 | 14.8 EB05 4.0 · IC025 +0.9 3/3 methods agree | No label text to screen | serious PRR 14.1 | no trial data cached |
| Application site irritation | 3 | 19.6 6.4–60.4ROR 19.8 · χ² 36 / p 1e-9 | 11.1 EB05 2.7 · IC025 +0.4 3/3 methods agree | No label text to screen | serious n=3 | 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 Avobenzone?
In FDA FAERS, the most frequently co-reported reaction terms for Avobenzone are skin cancer, neoplasm malignant, basal cell carcinoma, malignant melanoma, squamous cell carcinoma, application site erythema. 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 Avobenzone 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 Avobenzone 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, 10 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.