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adapalene Side Effects

Also known as: Differin

Analysis of 178,147 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

178,147

Death-Related

32

0.0% of reports

Hospitalizations

358

0.2% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
51,276
DRY SKIN
44,990
SKIN BURNING SENSATION
41,633
ACNE
39,264
ERYTHEMA
38,379
SKIN IRRITATION
26,225
SKIN EXFOLIATION
21,251
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION
16,186
RASH
15,520
OVERDOSE
13,210
PAIN OF SKIN
12,283
PRURITUS
11,826
HYPERSENSITIVITY
8,305
UNDERDOSE
4,949
CONDITION AGGRAVATED
4,946
RASH PAPULAR
4,147
PRODUCT USE IN UNAPPROVED INDICATION
3,964
RASH MACULAR
3,905
URTICARIA
3,298
SENSITIVE SKIN
2,791

Who Reports Side Effects

Gender Distribution

Female 122,669 (78%)
Male 34,451 (22%)
Unknown 75

Age Distribution

0-17 36,553 (42%)
18-44 43,798 (50%)
45-64 5,092 (6%)
65-74 970 (1%)
75+ 408 (0%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 32 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 12
DRUG INEFFECTIVE 6
PAIN 5
DYSPNOEA 4
EMOTIONAL DISTRESS 4
WEIGHT DECREASED 4
ANXIETY 3
ASTHMA 3
BONE DENSITY DECREASED 3
COMPLETED SUICIDE 3
CONSTIPATION 3
DEPRESSION 3
HAEMATEMESIS 3
MALAISE 3
OFF LABEL USE 3
OSTEOPENIA 3
PLATELET COUNT DECREASED 3
RASH 3
AMYLASE DECREASED 2
ANAEMIA 2

Reactions in Hospitalization Reports

Top reactions in 358 reports where hospitalization was an outcome.

Reaction Reports
DYSPNOEA 41
PAIN 41
ANXIETY 39
HYPERSENSITIVITY 32
PULMONARY EMBOLISM 29
FATIGUE 27
DEPRESSION 26
NAUSEA 24
INJURY 23
DIZZINESS 22
EMOTIONAL DISTRESS 22
DEEP VEIN THROMBOSIS 21
HEADACHE 21
RASH 21
MALAISE 19
ABDOMINAL PAIN 18
ERYTHEMA 18
PYREXIA 18
DRY SKIN 17
PARAESTHESIA 17

Nearby — Related Medications

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What the FAERS Data Reveals About adapalene Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 178,147 voluntary reports linked to adapalene and its brand equivalents (Differin), spanning 2004 through 2025. Of those, 32 (0.0%) listed death as an outcome and 358 (0.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 78% were female and 22% male; age distribution skews toward 18-44, with 43,798 reports in that bracket. The single most reported reaction is drug ineffective with 51,276 submissions, followed by dry skin and skin 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.