Drug · FAERS side-effect profile with label screen
Benzoyl Peroxide side effects: what 6,708 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Epsolay
openFDA label
Who reports
6,708 reports · 21% serious · 53 with death outcome · 77% female
openFDA FAERS counts, all years, deduplication not applied
Used for
EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults. EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults. ( 1 )
FDA label, Indications and Usage
What it is
EPSOLAY (benzoyl peroxide) cream is for topical use. Each gram of EPSOLAY contains 50 mg of benzoyl peroxide.
FDA label, Description section
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
Labeled adverse reaction 8Labeled (related wording) 7Reporting / coding artifact 4Not in label — unassessed 21
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
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. 81 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 |
|---|---|---|---|---|---|---|
| Acne | 1,480 | 61.9 59.2–64.8ROR 79.2 · χ² 87,213 / p <1e-300 | 60.7 EB05 58.1 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 27.0 · 98% consumer | no trial data cached |
| Skin irritation | 869 | 60.3 56.7–64.2ROR 69.1 · χ² 49,771 / p <1e-300 | 59.1 EB05 55.9 · IC025 +5.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=14 · 99% consumer | no trial data cached |
| Skin burning sensation | 975 | 43.4 41.0–46.0ROR 50.6 · χ² 39,946 / p <1e-300 | 42.8 EB05 40.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 26.9 · 98% consumer | no trial data cached |
| Pain of skin | 320 | 37.5 33.7–41.7ROR 39.3 · χ² 11,203 / p <1e-300 | 37.0 EB05 33.7 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.9 · 97% consumer | no trial data cached |
| Dry skin | 1,508 | 36.2 34.7–37.9ROR 46.5 · χ² 51,361 / p <1e-300 | 35.8 EB05 34.3 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.0 · 98% consumer | no trial data cached |
| Skin exfoliation | 562 | 21.3 19.7–23.0ROR 23.1 · χ² 10,808 / p <1e-300 | 21.1 EB05 19.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · 96% consumer | no trial data cached |
| Erythema (skin redness) | 1,160 | 17.8 16.8–18.7ROR 21.3 · χ² 18,402 / p <1e-300 | 17.7 EB05 16.8 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 · 95% consumer | no trial data cached |
| Rash papular | 119 | 16.6 13.9–19.9ROR 16.9 · χ² 1,726 / p <1e-300 | 16.5 EB05 14.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · 98% consumer | no trial data cached |
| Scar | 80 | 14.6 11.8–18.2ROR 14.8 · χ² 999 / p 1e-219 | 14.5 EB05 12.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 96% consumer | no trial data cached |
| Swelling face | 268 | 12.9 11.5–14.5ROR 13.4 · χ² 2,935 / p <1e-300 | 12.8 EB05 11.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 43.7 · 82% consumer | no trial data cached |
| Eye swelling | 151 | 12.8 10.9–15.0ROR 13.1 · χ² 1,629 / p <1e-300 | 12.7 EB05 11.1 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 52.7 · 89% consumer | no trial data cached |
| Dermatitis | 74 | 11.2 8.9–14.1ROR 11.3 · χ² 675 / p 3e-149 | 11.0 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · 93% consumer | no trial data cached |
| Inappropriate schedule of product administration | 624 | 11.1 10.3–11.9ROR 12.1 · χ² 5,732 / p <1e-300 | 11.0 EB05 10.3 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 0.8 · 98% consumer | no trial data cached |
| Skin fissures | 52 | 8.6 6.6–11.3ROR 8.7 · χ² 342 / p 9e-77 | 8.2 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=5 · 96% consumer | no trial data cached |
| Dermatitis contact | 31 | 8.6 6.0–12.2ROR 8.6 · χ² 199 / p 2e-45 | 7.9 EB05 5.7 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | no trial data cached |
| Underdose | 199 | 8.5 7.4–9.8ROR 8.8 · χ² 1,317 / p 1e-288 | 8.4 EB05 7.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | 99% consumer | no trial data cached |
| Rash macular | 92 | 8.3 6.8–10.1ROR 8.4 · χ² 581 / p 1e-128 | 8.0 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 · 97% consumer | no trial data cached |
| Overdose | 491 | 7.1 6.5–7.7ROR 7.6 · χ² 2,587 / p <1e-300 | 7.0 EB05 6.5 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 0.4 · 98% consumer | no trial data cached |
| Scab | 25 | 6.9 4.7–10.2ROR 6.9 · χ² 120 / p 3e-28 | 6.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=3 · 96% consumer | no trial data cached |
| Skin haemorrhage | 31 | 6.7 4.7–9.6ROR 6.8 · χ² 145 / p 1e-33 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=6 · 93% consumer | no trial data cached |
| Skin infection | 22 | 6.2 4.1–9.4ROR 6.2 · χ² 90 / p 1e-21 | 5.5 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 · 90% consumer | no trial data cached |
| Pharyngeal oedema | 30 | 6.0 4.2–8.6ROR 6.0 · χ² 121 / p 2e-28 | 5.5 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 21.6 | no trial data cached |
| Skin discolouration | 88 | 6.0 4.9–7.4ROR 6.1 · χ² 361 / p 7e-81 | 5.8 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 98% consumer | no trial data cached |
| Throat tightness | 48 | 5.6 4.2–7.4ROR 5.6 · χ² 175 / p 3e-40 | 5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 21.3 · 88% consumer | no trial data cached |
| Hypersensitivity (allergic reaction) | 326 | 5.5 5.0–6.1ROR 5.7 · χ² 1,206 / p 2e-264 | 5.5 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · 92% consumer | no trial data cached |
| Rash erythematous | 79 | 5.3 4.2–6.6ROR 5.3 · χ² 270 / p 6e-61 | 5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 89% consumer | no trial data cached |
| Application site erythema | 38 | 4.5 3.3–6.2ROR 4.5 · χ² 101 / p 6e-24 | 4.3 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=25 | no trial data cached |
| Drug ineffective (drug did not work) | 1,895 | 4.5 4.3–4.7ROR 5.9 · χ² 5,499 / p <1e-300 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.1 · 95% consumer | no trial data cached |
| Skin reaction | 20 | 4.4 2.9–6.9ROR 4.5 · χ² 50 / p 8e-13 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 | no trial data cached |
| Eyelid oedema | 16 | 4.3 2.6–7.0ROR 4.3 · χ² 37 / p 6e-10 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 | no trial data cached |
| Pruritus (itching) | 503 | 4.2 3.8–4.5ROR 4.4 · χ² 1,227 / p 5e-269 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 88% consumer | no trial data cached |
| Application site pain | 29 | 4.1 2.9–5.9ROR 4.1 · χ² 65 / p 3e-16 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=19 · 81% consumer | no trial data cached |
| Lip swelling | 43 | 4.0 3.0–5.5ROR 4.1 · χ² 96 / p 7e-23 | 3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.6 · 81% consumer | no trial data cached |
| Dermatitis allergic | 16 | 4.0 2.5–6.6ROR 4.0 · χ² 33 / p 4e-9 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.3 | no trial data cached |
| Posterior reversible encephalopathy syndrome | 12 | 3.9 2.2–6.9ROR 3.9 · χ² 23 / p 6e-7 | 3.5 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Urticaria (hives) | 199 | 3.7 3.3–4.3ROR 3.8 · χ² 400 / p 3e-89 | 3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 · 87% consumer | no trial data cached |
| Scratch | 12 | 3.6 2.1–6.4ROR 3.6 · χ² 20 / p 3e-6 | 3.2 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Rash | 478 | 3.4 3.2–3.8ROR 3.6 · χ² 845 / p 4e-186 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 88% consumer | no trial data cached |
| Folliculitis | 10 | 3.0 1.6–5.6ROR 3.0 · χ² 12 / p 3e-4 | 2.7 EB05 1.6 · IC025 +0.4 | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Blister | 54 | 3.0 2.3–3.9ROR 3.0 · χ² 71 / p 2e-17 | 3.0 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · 80% 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,895 | 4.5 4.3–4.7ROR 5.9 · χ² 5,499 / p <1e-300 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.1 · 95% consumer | no trial data cached |
| Dry skin | 1,508 | 36.2 34.7–37.9ROR 46.5 · χ² 51,361 / p <1e-300 | 35.8 EB05 34.3 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.0 · 98% consumer | no trial data cached |
| Acne | 1,480 | 61.9 59.2–64.8ROR 79.2 · χ² 87,213 / p <1e-300 | 60.7 EB05 58.1 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 27.0 · 98% consumer | no trial data cached |
| Erythema (skin redness) | 1,160 | 17.8 16.8–18.7ROR 21.3 · χ² 18,402 / p <1e-300 | 17.7 EB05 16.8 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 · 95% consumer | no trial data cached |
| Skin burning sensation | 975 | 43.4 41.0–46.0ROR 50.6 · χ² 39,946 / p <1e-300 | 42.8 EB05 40.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 26.9 · 98% consumer | no trial data cached |
| Skin irritation | 869 | 60.3 56.7–64.2ROR 69.1 · χ² 49,771 / p <1e-300 | 59.1 EB05 55.9 · IC025 +5.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=14 · 99% consumer | no trial data cached |
| Inappropriate schedule of product administration | 624 | 11.1 10.3–11.9ROR 12.1 · χ² 5,732 / p <1e-300 | 11.0 EB05 10.3 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 0.8 · 98% consumer | no trial data cached |
| Skin exfoliation | 562 | 21.3 19.7–23.0ROR 23.1 · χ² 10,808 / p <1e-300 | 21.1 EB05 19.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · 96% consumer | no trial data cached |
| Pruritus (itching) | 503 | 4.2 3.8–4.5ROR 4.4 · χ² 1,227 / p 5e-269 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 88% consumer | no trial data cached |
| Overdose | 491 | 7.1 6.5–7.7ROR 7.6 · χ² 2,587 / p <1e-300 | 7.0 EB05 6.5 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 0.4 · 98% consumer | no trial data cached |
| Rash | 478 | 3.4 3.2–3.8ROR 3.6 · χ² 845 / p 4e-186 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 88% consumer | no trial data cached |
| Hypersensitivity (allergic reaction) | 326 | 5.5 5.0–6.1ROR 5.7 · χ² 1,206 / p 2e-264 | 5.5 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · 92% consumer | no trial data cached |
| Pain of skin | 320 | 37.5 33.7–41.7ROR 39.3 · χ² 11,203 / p <1e-300 | 37.0 EB05 33.7 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.9 · 97% consumer | no trial data cached |
| Swelling face | 268 | 12.9 11.5–14.5ROR 13.4 · χ² 2,935 / p <1e-300 | 12.8 EB05 11.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 43.7 · 82% consumer | no trial data cached |
| Urticaria (hives) | 199 | 3.7 3.3–4.3ROR 3.8 · χ² 400 / p 3e-89 | 3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 · 87% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Acne — n=1,480, PRR 61.9
- Skin burning sensation — n=975, PRR 43.4
- Skin exfoliation — n=562, PRR 21.3
- Rash papular — n=119, PRR 16.6
- Scar — n=80, PRR 14.6
- Swelling face — n=268, PRR 12.9
- Skin fissures — n=52, PRR 8.6
- Rash macular — n=92, PRR 8.3
- Scab — n=25, PRR 6.9
- Skin haemorrhage — n=31, PRR 6.7
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 Benzoyl Peroxide?
In FDA FAERS, the most frequently co-reported reaction terms for Benzoyl Peroxide are dry skin, acne, erythema, skin burning sensation, skin irritation, skin exfoliation. 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 Benzoyl Peroxide have an FDA boxed warning?
No. The FDA label retrieved for Benzoyl Peroxide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Benzoyl Peroxide 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 641981e6-460b-44dd-8146-306c47e5367c, effective 20250811; matched on
openfda.generic_name.exact:"BENZOYL PEROXIDE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 121 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.