Drug · FAERS side-effect profile with label screen

Adapalene and Benzoyl Peroxide side effects: what 412 FDA adverse event reports show

Adapalene And Benzoyl Peroxide · 16 reaction terms · 454 drug–reaction co-reports · data 2026-09-14

Drug class

Retinoid

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Adapalene (Adapalene)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

412 reports · 15% serious · 0 with death outcome · 71% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )

FDA label, Indications and Usage

What it is

Adapalene Gel USP, 0.3% contains adapalene USP, 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbopol 980, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment.

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 14 strongest signals

Labeled adverse reaction 4Labeled (related wording) 5Likely indication confounding 1Not in label — unassessed 4

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.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Pain of skin	33	62.3 44.9–86.4ROR 67.6 · χ² 1,929 / p <1e-300	60.1 EB05 44.8 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	91% consumer	no trial data cached
Skin burning sensation	78	55.9 45.7–68.2ROR 68.7 · χ² 4,158 / p <1e-300	55.1 EB05 45.6 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 20.8 · 86% consumer	no trial data cached
Skin irritation	45	50.0 37.9–65.8ROR 56.0 · χ² 2,113 / p <1e-300	48.9 EB05 38.1 · IC025 +4.5 3/3 methods agree	Labeled (related wording) related wording	serious n=2 · 71% consumer	no trial data cached
Application site erythema	18	34.8 22.2–54.7ROR 36.4 · χ² 558 / p 9e-124	33.7 EB05 22.5 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious n=2	no trial data cached
Acne	44	29.4 22.2–38.9ROR 32.8 · χ² 1,183 / p 2e-259	29.1 EB05 22.5 · IC025 +4.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 37.1 · 91% consumer	no trial data cached
Dermatitis	11	27.0 15.1–48.4ROR 27.7 · χ² 250 / p 1e-56	25.8 EB05 15.2 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.8	no trial data cached
Dry skin	64	24.8 19.8–31.0ROR 29.1 · χ² 1,445 / p <1e-300	24.6 EB05 19.9 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.3 · 88% consumer	no trial data cached
Skin exfoliation	40	24.5 18.3–32.9ROR 27.0 · χ² 882 / p 5e-194	24.3 EB05 18.6 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.8 · 88% consumer	no trial data cached
Application site pain	9	20.8 10.9–39.7ROR 21.3 · χ² 151 / p 6e-35	19.4 EB05 9.8 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious n=1	no trial data cached
Dermatitis allergic	5	20.4 8.5–48.8ROR 20.7 · χ² 74 / p 4e-18	16.2 EB05 5.1 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Rash papular	9	20.4 10.7–38.9ROR 20.8 · χ² 147 / p 3e-34	18.9 EB05 9.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Erythema (skin redness)	78	19.3 15.8–23.6ROR 23.6 · χ² 1,351 / p 4e-296	19.3 EB05 15.9 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.1 · 76% consumer	no trial data cached
Application site pruritus	6	13.5 6.1–29.8ROR 13.6 · χ² 57 / p 2e-14	9.8 EB05 3.9 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious n=1	no trial data cached
Dermatitis atopic	7	7.1 3.4–14.9ROR 7.2 · χ² 31 / p 1e-8	5.2 EB05 2.7 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	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
Erythema (skin redness)	78	19.3 15.8–23.6ROR 23.6 · χ² 1,351 / p 4e-296	19.3 EB05 15.9 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.1 · 76% consumer	no trial data cached
Skin burning sensation	78	55.9 45.7–68.2ROR 68.7 · χ² 4,158 / p <1e-300	55.1 EB05 45.6 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 20.8 · 86% consumer	no trial data cached
Dry skin	64	24.8 19.8–31.0ROR 29.1 · χ² 1,445 / p <1e-300	24.6 EB05 19.9 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.3 · 88% consumer	no trial data cached
Skin irritation	45	50.0 37.9–65.8ROR 56.0 · χ² 2,113 / p <1e-300	48.9 EB05 38.1 · IC025 +4.5 3/3 methods agree	Labeled (related wording) related wording	serious n=2 · 71% consumer	no trial data cached
Acne	44	29.4 22.2–38.9ROR 32.8 · χ² 1,183 / p 2e-259	29.1 EB05 22.5 · IC025 +4.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 37.1 · 91% consumer	no trial data cached
Skin exfoliation	40	24.5 18.3–32.9ROR 27.0 · χ² 882 / p 5e-194	24.3 EB05 18.6 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.8 · 88% consumer	no trial data cached
Pain of skin	33	62.3 44.9–86.4ROR 67.6 · χ² 1,929 / p <1e-300	60.1 EB05 44.8 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	91% consumer	no trial data cached
Application site erythema	18	34.8 22.2–54.7ROR 36.4 · χ² 558 / p 9e-124	33.7 EB05 22.5 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious n=2	no trial data cached
Dermatitis	11	27.0 15.1–48.4ROR 27.7 · χ² 250 / p 1e-56	25.8 EB05 15.2 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.8	no trial data cached
Rash papular	9	20.4 10.7–38.9ROR 20.8 · χ² 147 / p 3e-34	18.9 EB05 9.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Application site pain	9	20.8 10.9–39.7ROR 21.3 · χ² 151 / p 6e-35	19.4 EB05 9.8 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious n=1	no trial data cached
Dermatitis atopic	7	7.1 3.4–14.9ROR 7.2 · χ² 31 / p 1e-8	5.2 EB05 2.7 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Application site pruritus	6	13.5 6.1–29.8ROR 13.6 · χ² 57 / p 2e-14	9.8 EB05 3.9 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious n=1	no trial data cached
Dermatitis allergic	5	20.4 8.5–48.8ROR 20.7 · χ² 74 / p 4e-18	16.2 EB05 5.1 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Application site irritation	4	16.4 6.2–43.4ROR 16.5 · χ² 43 / p 2e-11	10.5 EB05 3.2 · IC025 +0.8 3/3 methods agree	Labeled (related wording) related wording	serious n=1	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.

Skin burning sensation — n=78, PRR 55.9
Skin exfoliation — n=40, PRR 24.5

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 Adapalene and Benzoyl Peroxide?

In FDA FAERS, the most frequently co-reported reaction terms for Adapalene and Benzoyl Peroxide are erythema, skin burning sensation, dry skin, skin irritation, acne, 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 Adapalene and Benzoyl Peroxide have an FDA boxed warning?

No. The FDA label retrieved for Adapalene and Benzoyl Peroxide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Adapalene and 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 5dd6d825-f7c4-4a86-82cc-fcbb41df8542, effective 20250326; matched on openfda.generic_name.exact:"ADAPALENE" 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, field patient.drug.openfda.generic_name.exact, 16 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.