PlainMeds provides educational information only. This is not medical advice. Always consult your doctor or pharmacist.

crisaborole Side Effects

Also known as: Eucrisa

Analysis of 9,400 adverse event reports submitted to the FDA from 2013 to 2025.

Total Reports

9,400

Death-Related

24

0.3% of reports

Hospitalizations

142

1.5% of reports

Top Indication

Dermatitis Atopic

Most Reported Adverse Reactions

DRUG INEFFECTIVE
1,957
APPLICATION SITE PAIN
1,415
BURNING SENSATION
985
OFF LABEL USE
746
CONDITION AGGRAVATED
699
PRURITUS
624
RASH
597
PAIN
526
ECZEMA
447
DERMATITIS ATOPIC
421
ERYTHEMA
370
PRODUCT USE IN UNAPPROVED INDICATION
333
DRUG HYPERSENSITIVITY
258
DRY SKIN
250
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION
241
APPLICATION SITE ERYTHEMA
234
SKIN BURNING SENSATION
231
THERAPEUTIC PRODUCT EFFECT INCOMPLETE
219
PRODUCT USE ISSUE
203
SKIN EXFOLIATION
175

Who Reports Side Effects

Gender Distribution

Female 5,420 (65%)
Male 2,864 (35%)
Unknown 6

Age Distribution

0-17 2,166 (32%)
18-44 1,614 (24%)
45-64 1,699 (25%)
65-74 835 (12%)
75+ 444 (7%)

Reporting Trend by Year

13
14
17
18
19
20
21
22
23
24
25

Reactions in Death Reports

Top reactions reported in 24 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 19
OFF LABEL USE 3
ACCIDENTAL DEATH 2
BURNING SENSATION 2
CONDITION AGGRAVATED 2
PRURITUS 2
ACNE 1
APPLICATION SITE PAIN 1
APPLICATION SITE PRURITUS 1
ASTHMA 1
COMA 1
DEAFNESS UNILATERAL 1
DEMENTIA 1
DRUG EFFECTIVE FOR UNAPPROVED INDICATION 1
DRUG INEFFECTIVE 1
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 1
DYSPNOEA 1
ERYTHEMA 1
INFLAMMATION 1
NEOPLASM MALIGNANT 1

Reactions in Hospitalization Reports

Top reactions in 142 reports where hospitalization was an outcome.

Reaction Reports
ECZEMA 22
OFF LABEL USE 21
PRURITUS 20
RASH 20
FATIGUE 18
ERYTHEMA 16
CONDITION AGGRAVATED 15
ARTHRALGIA 14
DRUG HYPERSENSITIVITY 14
NASOPHARYNGITIS 14
PYREXIA 14
CHEST PAIN 13
PAIN 13
UPPER RESPIRATORY TRACT INFECTION 13
CELLULITIS 12
NAUSEA 12
PAIN IN EXTREMITY 12
URINARY TRACT INFECTION 12
DRUG INEFFECTIVE 11
HYPERSENSITIVITY 11

Nearby — Related Medications

Compare crisaborole vs adapalene →

What the FAERS Data Reveals About crisaborole Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 9,400 voluntary reports linked to crisaborole and its brand equivalents (Eucrisa), spanning 2013 through 2025. Of those, 24 (0.3%) listed death as an outcome and 142 (1.5%) involved hospitalization. The most common indication reported alongside adverse events was Dermatitis Atopic.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 65% were female and 35% male; age distribution skews toward 0-17, with 2,166 reports in that bracket. The single most reported reaction is drug ineffective with 1,957 submissions, followed by application site pain and burning sensation.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.