Drug · FAERS side-effect profile with label screen
Crisaborole side effects: what 9,540 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Eucrisa
openFDA label
Who reports
9,540 reports · 8% serious · 25 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
EUCRISA is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. EUCRISA is a phosphodiesterase 4 inhibitor indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. ( 1 )
FDA label, Indications and Usage
What it is
EUCRISA contains 2% crisaborole (w/w) in a petrolatum-based, white to off-white ointment and is for topical use. The active ingredient, crisaborole, is a phosphodiesterase-4 (PDE-4) inhibitor. Crisaborole is described chemically as 5-(4-cyanophenoxy)-1,3-dihydro-1-hydroxy-[2,1]-benzoxaborole.
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 1Labeled (related wording) 17Likely indication confounding 2Reporting / coding artifact 2Not in label — unassessed 18
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. 548 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 |
|---|---|---|---|---|---|---|
| Eczema infantile | 10 | 281.6 145.7–544.0ROR 281.9 · χ² 2,232 / p <1e-300 | 169.4 EB05 98.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Application site pain | 1,416 | 151.1 143.8–158.9ROR 177.3 · χ² 197,495 / p <1e-300 | 141.1 EB05 135.0 · IC025 +7.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=24 | no trial data cached |
| Eyelid irritation | 72 | 66.2 52.4–83.7ROR 66.7 · χ² 4,426 / p <1e-300 | 63.3 EB05 51.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=16 · ♀ 86% (drug 65%) | no trial data cached |
| Application site inflammation | 28 | 45.8 31.5–66.5ROR 45.9 · χ² 1,158 / p 5e-254 | 43.6 EB05 31.7 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Application site paraesthesia | 23 | 39.3 26.0–59.3ROR 39.4 · χ² 805 / p 2e-177 | 37.5 EB05 26.3 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Application site swelling | 78 | 34.9 27.9–43.6ROR 35.1 · χ² 2,492 / p <1e-300 | 34.1 EB05 28.2 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=3 | no trial data cached |
| Burning sensation | 985 | 31.3 29.5–33.2ROR 34.8 · χ² 28,552 / p <1e-300 | 30.9 EB05 29.3 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.1 | no trial data cached |
| Application site warmth | 17 | 29.6 18.3–47.7ROR 29.6 · χ² 435 / p 7e-97 | 28.3 EB05 18.7 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Application site burn | 62 | 27.9 21.7–35.8ROR 28.0 · χ² 1,559 / p <1e-300 | 27.3 EB05 22.1 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=6 | no trial data cached |
| Eyelid pain | 22 | 25.2 16.6–38.3ROR 25.3 · χ² 482 / p 5e-107 | 24.4 EB05 17.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Application site urticaria | 22 | 21.6 14.2–32.8ROR 21.6 · χ² 407 / p 9e-91 | 21.0 EB05 14.5 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Eczema | 459 | 20.2 18.5–22.1ROR 21.2 · χ² 8,315 / p <1e-300 | 20.0 EB05 18.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 61.9 | no trial data cached |
| Dermatitis atopic | 446 | 19.8 18.1–21.7ROR 20.7 · χ² 7,886 / p <1e-300 | 19.6 EB05 18.1 · IC025 +4.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=29 | no trial data cached |
| Application site erythema | 234 | 19.7 17.4–22.4ROR 20.2 · χ² 4,106 / p <1e-300 | 19.5 EB05 17.5 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Skin hypopigmentation | 14 | 17.7 10.5–29.9ROR 17.7 · χ² 202 / p 3e-46 | 16.8 EB05 10.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Application site discolouration | 32 | 17.4 12.3–24.6ROR 17.5 · χ² 475 / p 2e-105 | 17.0 EB05 12.5 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Application site pruritus | 139 | 13.5 11.5–16.0ROR 13.7 · χ² 1,593 / p <1e-300 | 13.4 EB05 11.6 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Drug administered to patient of inappropriate age | 44 | 13.4 10.0–18.0ROR 13.4 · χ² 489 / p 1e-108 | 13.1 EB05 10.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | ♀ 39% (drug 65%) | no trial data cached |
| Sensitivity to weather change | 28 | 11.8 8.2–17.1ROR 11.8 · χ² 265 / p 7e-60 | 11.2 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=4 · 86% consumer | no trial data cached |
| Application site exfoliation | 22 | 11.7 7.7–17.8ROR 11.7 · χ² 204 / p 1e-46 | 10.9 EB05 7.2 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious n=2 | no trial data cached |
| Dermatitis | 106 | 11.3 9.3–13.7ROR 11.4 · χ² 980 / p 2e-215 | 11.1 EB05 9.4 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 40.7 | no trial data cached |
| Skin weeping | 17 | 11.3 7.0–18.2ROR 11.3 · χ² 148 / p 2e-34 | 10.1 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Allergic reaction to excipient | 10 | 11.2 6.0–20.8ROR 11.2 · χ² 83 / p 5e-20 | 9.1 EB05 4.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Drug effective for unapproved indication | 146 | 11.0 9.4–13.0ROR 11.2 · χ² 1,317 / p 1e-288 | 10.9 EB05 9.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Application site dryness | 17 | 11.0 6.8–17.7ROR 11.0 · χ² 144 / p 2e-33 | 9.8 EB05 6.0 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Sleep disorder due to a general medical condition | 78 | 10.6 8.5–13.3ROR 10.7 · χ² 669 / p 7e-148 | 10.4 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Skin fissures | 91 | 10.6 8.7–13.1ROR 10.7 · χ² 782 / p 2e-172 | 10.4 EB05 8.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Scratch | 47 | 10.0 7.5–13.3ROR 10.1 · χ² 371 / p 5e-83 | 9.6 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Skin discomfort | 12 | 10.0 5.7–17.6ROR 10.0 · χ² 88 / p 4e-21 | 8.2 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Skin haemorrhage | 63 | 9.6 7.5–12.3ROR 9.7 · χ² 477 / p 5e-106 | 9.3 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Drug ineffective for unapproved indication | 243 | 9.6 8.5–10.9ROR 9.8 · χ² 1,865 / p <1e-300 | 9.5 EB05 8.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 | no trial data cached |
| Application site vesicles | 28 | 9.5 6.5–13.7ROR 9.5 · χ² 203 / p 2e-46 | 8.7 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Application site irritation | 52 | 9.2 7.0–12.1ROR 9.3 · χ² 371 / p 4e-83 | 8.8 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=2 | no trial data cached |
| Skin disorder | 139 | 9.2 7.8–10.9ROR 9.3 · χ² 1,007 / p 2e-221 | 9.0 EB05 7.8 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.8 | no trial data cached |
| Cheilitis (inflamed lips) | 22 | 9.0 5.9–13.6ROR 9.0 · χ² 147 / p 3e-34 | 8.0 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=17 · 91% clinician | no trial data cached |
| Skin erosion | 11 | 7.6 4.2–13.7ROR 7.6 · χ² 56 / p 3e-14 | 6.0 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Product physical consistency issue | 18 | 7.3 4.6–11.5ROR 7.3 · χ² 91 / p 9e-22 | 6.3 EB05 4.1 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Skin burning sensation | 233 | 7.2 6.4–8.2ROR 7.4 · χ² 1,242 / p 2e-272 | 7.1 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.6 | no trial data cached |
| Application site rash | 45 | 7.2 5.4–9.6ROR 7.2 · χ² 233 / p 7e-53 | 6.8 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious n=2 | no trial data cached |
| Thermal burn | 23 | 7.1 4.7–10.7ROR 7.2 · χ² 115 / p 4e-27 | 6.4 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=7 | 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) | 1,986 | 3.3 3.2–3.5ROR 3.9 · χ² 3,426 / p <1e-300 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 | no trial data cached |
| Application site pain | 1,416 | 151.1 143.8–158.9ROR 177.3 · χ² 197,495 / p <1e-300 | 141.1 EB05 135.0 · IC025 +7.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=24 | no trial data cached |
| Burning sensation | 985 | 31.3 29.5–33.2ROR 34.8 · χ² 28,552 / p <1e-300 | 30.9 EB05 29.3 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.1 | no trial data cached |
| Off label use (used outside approved label) | 755 | 1.9 1.8–2.0ROR 2.0 · χ² 342 / p 1e-76 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 4.6 | no trial data cached |
| Condition aggravated | 708 | 5.2 4.8–5.5ROR 5.5 · χ² 2,402 / p <1e-300 | 5.1 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 | no trial data cached |
| Pruritus (itching) | 643 | 3.7 3.5–4.0ROR 3.9 · χ² 1,312 / p 1e-287 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Rash | 616 | 3.1 2.9–3.4ROR 3.3 · χ² 906 / p 3e-199 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Pain | 528 | 1.9 1.7–2.1ROR 1.9 · χ² 226 / p 3e-51 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Eczema | 459 | 20.2 18.5–22.1ROR 21.2 · χ² 8,315 / p <1e-300 | 20.0 EB05 18.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 61.9 | no trial data cached |
| Dermatitis atopic | 446 | 19.8 18.1–21.7ROR 20.7 · χ² 7,886 / p <1e-300 | 19.6 EB05 18.1 · IC025 +4.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=29 | no trial data cached |
| Erythema (skin redness) | 372 | 4.0 3.6–4.4ROR 4.1 · χ² 837 / p 3e-184 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 | no trial data cached |
| Product use in unapproved indication | 336 | 3.0 2.7–3.4ROR 3.1 · χ² 458 / p 5e-102 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Dry skin | 262 | 4.4 3.9–4.9ROR 4.5 · χ² 684 / p 4e-151 | 4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.2 | no trial data cached |
| Drug hypersensitivity | 261 | 3.0 2.6–3.3ROR 3.0 · χ² 339 / p 6e-76 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.4 | no trial data cached |
| Drug ineffective for unapproved indication | 243 | 9.6 8.5–10.9ROR 9.8 · χ² 1,865 / p <1e-300 | 9.5 EB05 8.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 | 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.
- Eyelid irritation — n=72, PRR 66.2
- Eyelid pain — n=22, PRR 25.2
- Eczema — n=459, PRR 20.2
- Drug administered to patient of inappropriate age — n=44, PRR 13.4
- Sensitivity to weather change — n=28, PRR 11.8
- Drug effective for unapproved indication — n=146, PRR 11.0
- Sleep disorder due to a general medical condition — n=78, PRR 10.6
- Skin fissures — n=91, PRR 10.6
- Scratch — n=47, PRR 10.0
- Skin haemorrhage — n=63, PRR 9.6
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 Crisaborole?
In FDA FAERS, the most frequently co-reported reaction terms for Crisaborole are application site pain, burning sensation, pruritus, rash, pain, eczema. 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 Crisaborole have an FDA boxed warning?
No. The FDA label retrieved for Crisaborole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Crisaborole 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 609b77de-1ca3-4783-b8f5-01a9c0f1d77d, effective 20250923; matched on
openfda.generic_name.exact:"CRISABOROLE") - 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, 588 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.