Drug · FAERS side-effect profile with label screen
Adapalene side effects: what 181,054 FDA adverse event reports show
Who reports
181,054 reports · 1% serious · 33 with death outcome · 78% 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 is a naphthoic acid that is CD437 in which the phenolic hydroxy group has been converted to its methyl ether. It has a role as a non-steroidal anti-inflammatory drug, a dermatologic drug and an EC 2.7.11.22 (cyclin-dependent kinase) inhibitor.
PubChem CID 60164 (ChEBI)
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 4Labeled (related wording) 6Likely indication confounding 1Reporting / coding artifact 3Not in label — unassessed 26
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.
- 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. 699 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 |
|---|---|---|---|---|---|---|
| Chemical burn of skin | 1,801 | 282.2 258.9–307.6ROR 285.0 · χ² 144,494 / p <1e-300 | 81.5 EB05 78.4 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=9 · 99% consumer | not reported in cached trials |
| Chemical peel of skin | 18 | 203.9 94.1–441.8ROR 203.9 · χ² 1,226 / p 7e-269 | 68.4 EB05 45.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Skin fragility | 1,480 | 179.9 165.8–195.2ROR 181.4 · χ² 101,682 / p <1e-300 | 70.1 EB05 67.1 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Skin burning sensation | 41,912 | 167.8 165.5–170.3ROR 218.1 · χ² 2,810,579 / p <1e-300 | 68.2 EB05 67.7 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 49.3 · 99% consumer | not reported in cached trials |
| Skin irritation | 26,485 | 159.6 156.7–162.5ROR 186.7 · χ² 1,736,437 / p <1e-300 | 66.8 EB05 66.2 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=24 · 100% consumer | not reported in cached trials |
| Acne | 39,434 | 125.0 123.3–126.7ROR 159.5 · χ² 2,314,293 / p <1e-300 | 59.9 EB05 59.5 · IC025 +5.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 39.1 · 100% consumer | not reported in cached trials |
| Acne cystic | 1,447 | 106.6 99.2–114.5ROR 107.4 · χ² 77,938 / p <1e-300 | 55.4 EB05 53.0 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=4 · 99% consumer | not reported in cached trials |
| Pain of skin | 12,321 | 97.4 95.2–99.8ROR 104.5 · χ² 632,961 / p <1e-300 | 52.8 EB05 52.1 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 45.9 · 99% consumer | not reported in cached trials |
| First degree chemical burn of skin | 11 | 95.9 42.9–214.0ROR 95.9 · χ² 509 / p 6e-113 | 48.3 EB05 28.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Dilated pores | 39 | 86.6 57.1–131.4ROR 86.7 · χ² 1,822 / p <1e-300 | 48.4 EB05 37.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Seborrhoea | 1,575 | 86.5 81.0–92.3ROR 87.2 · χ² 75,436 / p <1e-300 | 49.5 EB05 47.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=2 · 100% consumer | not reported in cached trials |
| Sensitive skin | 2,824 | 74.0 70.6–77.6ROR 75.2 · χ² 123,018 / p <1e-300 | 45.1 EB05 43.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=4 · 100% consumer | not reported in cached trials |
| Acne pustular | 287 | 62.3 53.9–71.9ROR 62.4 · χ² 11,128 / p <1e-300 | 40.4 EB05 36.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=2 · 99% consumer | not reported in cached trials |
| Skin hypopigmentation | 610 | 61.6 55.9–68.0ROR 61.9 · χ² 23,532 / p <1e-300 | 40.2 EB05 37.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | 99% consumer | not reported in cached trials |
| Dry skin | 45,426 | 61.0 60.4–61.6ROR 81.1 · χ² 1,753,222 / p <1e-300 | 40.0 EB05 39.7 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.4 · 100% consumer | NCT00421993: 60/418 (14.4%) on Adapalene |
| Skin discomfort | 861 | 55.3 51.0–60.0ROR 55.6 · χ² 30,826 / p <1e-300 | 37.5 EB05 35.4 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=3 · 100% consumer | not reported in cached trials |
| Skin hyperpigmentation | 2,742 | 54.3 51.9–56.8ROR 55.1 · χ² 97,013 / p <1e-300 | 37.0 EB05 35.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=6 · 99% consumer | not reported in cached trials |
| Skin swelling | 2,310 | 43.0 41.0–45.1ROR 43.5 · χ² 68,680 / p <1e-300 | 31.4 EB05 30.4 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=8 · 99% consumer | not reported in cached trials |
| Skin exfoliation | 21,395 | 40.0 39.4–40.6ROR 45.2 · χ² 603,495 / p <1e-300 | 29.8 EB05 29.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · 99% consumer | not reported in cached trials |
| Chemical burn | 247 | 32.0 27.8–36.9ROR 32.1 · χ² 5,762 / p <1e-300 | 25.1 EB05 22.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=4 · 97% consumer | not reported in cached trials |
| Skin tightness | 903 | 27.5 25.5–29.5ROR 27.6 · χ² 18,516 / p <1e-300 | 22.3 EB05 21.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=6 · 99% consumer | not reported in cached trials |
| Erythema (skin redness) | 38,589 | 26.7 26.4–26.9ROR 33.6 · χ² 779,070 / p <1e-300 | 21.8 EB05 21.6 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 · 99% consumer | not reported in cached trials |
| Rash papular | 4,148 | 26.1 25.2–27.0ROR 26.7 · χ² 81,387 / p <1e-300 | 21.4 EB05 20.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · 99% consumer | not reported in cached trials |
| Periorbital irritation | 38 | 15.5 11.0–21.7ROR 15.5 · χ² 440 / p 5e-98 | 13.5 EB05 10.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Eyelid exfoliation | 91 | 15.1 12.1–18.7ROR 15.1 · χ² 1,041 / p 1e-228 | 13.3 EB05 11.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=2 · 99% consumer | not reported in cached trials |
| Rash macular | 3,915 | 14.6 14.1–15.1ROR 14.9 · χ² 43,888 / p <1e-300 | 13.0 EB05 12.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · 99% consumer | not reported in cached trials |
| Skin fissures | 2,038 | 13.9 13.3–14.6ROR 14.1 · χ² 21,760 / p <1e-300 | 12.5 EB05 12.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=4 · 99% consumer | not reported in cached trials |
| Dermatitis | 2,058 | 12.7 12.1–13.3ROR 12.8 · χ² 19,918 / p <1e-300 | 11.5 EB05 11.1 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 · 98% consumer | not reported in cached trials |
| Skin warm | 569 | 12.5 11.4–13.6ROR 12.5 · χ² 5,393 / p <1e-300 | 11.3 EB05 10.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | 99% consumer | not reported in cached trials |
| Scar | 1,632 | 12.1 11.5–12.7ROR 12.2 · χ² 14,997 / p <1e-300 | 11.0 EB05 10.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.4 · 99% consumer | not reported in cached trials |
| Inappropriate schedule of product administration | 16,235 | 11.6 11.4–11.8ROR 12.7 · χ² 144,171 / p <1e-300 | 10.6 EB05 10.5 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 99% consumer | not reported in cached trials |
| Scab | 1,036 | 11.6 10.8–12.3ROR 11.6 · χ² 9,065 / p <1e-300 | 10.6 EB05 10.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=7 · 99% consumer | not reported in cached trials |
| Skin injury | 290 | 11.1 9.8–12.5ROR 11.1 · χ² 2,412 / p <1e-300 | 10.1 EB05 9.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Eyelid irritation | 191 | 9.7 8.3–11.2ROR 9.7 · χ² 1,360 / p 6e-298 | 8.9 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=2 · 97% consumer | not reported in cached trials |
| Eyelid skin dryness | 89 | 9.5 7.6–11.8ROR 9.5 · χ² 614 / p 7e-136 | 8.6 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | 99% consumer | not reported in cached trials |
| Skin reaction | 968 | 8.5 8.0–9.1ROR 8.5 · χ² 5,947 / p <1e-300 | 7.9 EB05 7.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.5 · 99% consumer | NCT00421993: 60/418 (14.4%) on Adapalene |
| Underdose | 4,949 | 8.3 8.1–8.6ROR 8.6 · χ² 29,911 / p <1e-300 | 7.8 EB05 7.7 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · 99% consumer | not reported in cached trials |
| Skin texture abnormal | 62 | 8.1 6.3–10.5ROR 8.1 · χ² 355 / p 2e-79 | 7.3 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Skin haemorrhage | 893 | 7.6 7.1–8.1ROR 7.6 · χ² 4,777 / p <1e-300 | 7.1 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | 99% consumer | not reported in cached trials |
| Overdose | 13,210 | 7.5 7.3–7.6ROR 8.0 · χ² 70,071 / p <1e-300 | 7.1 EB05 7.0 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.3 · 99% consumer | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Adapalene as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (2 of 40 signal terms matched).
- NCT00421993 — A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne (N=1670, PHASE3; 8 AE terms posted; arms: Adapalene/Benzoyl Peroxide Gel; Adapalene Gel; Benzoyl Peroxide Gel; Gel Vehicle)
- NCT00422240 — Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne V (N=1668, PHASE3; 8 AE terms posted; arms: Adapalene/Benzoyl Peroxide Gel; Adapalene Gel, 0.1%; Benzoyl Peroxide Gel 2.5%; Gel Vehicle)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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) | 52,992 | 4.8 4.8–4.9ROR 6.4 · χ² 164,040 / p <1e-300 | 4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.0 · 100% consumer | not reported in cached trials |
| Dry skin | 45,426 | 61.0 60.4–61.6ROR 81.1 · χ² 1,753,222 / p <1e-300 | 40.0 EB05 39.7 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.4 · 100% consumer | NCT00421993: 60/418 (14.4%) on Adapalene |
| Skin burning sensation | 41,912 | 167.8 165.5–170.3ROR 218.1 · χ² 2,810,579 / p <1e-300 | 68.2 EB05 67.7 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 49.3 · 99% consumer | not reported in cached trials |
| Acne | 39,434 | 125.0 123.3–126.7ROR 159.5 · χ² 2,314,293 / p <1e-300 | 59.9 EB05 59.5 · IC025 +5.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 39.1 · 100% consumer | not reported in cached trials |
| Erythema (skin redness) | 38,589 | 26.7 26.4–26.9ROR 33.6 · χ² 779,070 / p <1e-300 | 21.8 EB05 21.6 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 · 99% consumer | not reported in cached trials |
| Skin irritation | 26,485 | 159.6 156.7–162.5ROR 186.7 · χ² 1,736,437 / p <1e-300 | 66.8 EB05 66.2 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=24 · 100% consumer | not reported in cached trials |
| Skin exfoliation | 21,395 | 40.0 39.4–40.6ROR 45.2 · χ² 603,495 / p <1e-300 | 29.8 EB05 29.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · 99% consumer | not reported in cached trials |
| Inappropriate schedule of product administration | 16,235 | 11.6 11.4–11.8ROR 12.7 · χ² 144,171 / p <1e-300 | 10.6 EB05 10.5 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 99% consumer | not reported in cached trials |
| Rash | 15,728 | 4.3 4.3–4.4ROR 4.6 · χ² 39,514 / p <1e-300 | 4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 99% consumer | not reported in cached trials |
| Overdose | 13,210 | 7.5 7.3–7.6ROR 8.0 · χ² 70,071 / p <1e-300 | 7.1 EB05 7.0 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.3 · 99% consumer | not reported in cached trials |
| Pain of skin | 12,321 | 97.4 95.2–99.8ROR 104.5 · χ² 632,961 / p <1e-300 | 52.8 EB05 52.1 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 45.9 · 99% consumer | not reported in cached trials |
| Pruritus (itching) | 11,881 | 3.7 3.7–3.8ROR 3.9 · χ² 23,378 / p <1e-300 | 3.6 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 99% consumer | not reported in cached trials |
| Hypersensitivity (allergic reaction) | 8,394 | 5.4 5.3–5.6ROR 5.7 · χ² 29,347 / p <1e-300 | 5.2 EB05 5.1 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.3 · 99% consumer | not reported in cached trials |
| Condition aggravated | 5,272 | 2.0 2.0–2.1ROR 2.1 · χ² 2,787 / p <1e-300 | 2.0 EB05 2.0 · IC025 +1.0 | Reporting / coding artifact | serious PRR 1.5 · 99% consumer | not reported in cached trials |
| Underdose | 4,949 | 8.3 8.1–8.6ROR 8.6 · χ² 29,911 / p <1e-300 | 7.8 EB05 7.7 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · 99% consumer | not reported in cached trials |
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.
- Chemical burn of skin — n=1,801, PRR 282.2
- Skin fragility — n=1,480, PRR 179.9
- Skin burning sensation — n=41,912, PRR 167.8
- Acne cystic — n=1,447, PRR 106.6
- Dilated pores — n=39, PRR 86.6
- Seborrhoea — n=1,575, PRR 86.5
- Sensitive skin — n=2,824, PRR 74.0
- Acne pustular — n=287, PRR 62.3
- Skin hypopigmentation — n=610, PRR 61.6
- Skin hyperpigmentation — n=2,742, PRR 54.3
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?
In FDA FAERS, the most frequently co-reported reaction terms for Adapalene are dry skin, skin burning sensation, acne, erythema, 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 Adapalene have an FDA boxed warning?
No. The FDA label retrieved for Adapalene has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Adapalene 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") - PubChem CID 60164 description (ChEBI)
- 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, 739 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
ADAPALENE, results-bearing studies sorted by enrollment)
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.