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benzoyl peroxide Side Effects

Also known as: Benzac, PanOxyl

Analysis of 6,624 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

6,624

Death-Related

51

0.8% of reports

Hospitalizations

370

5.6% of reports

Top Indication

Acne

Most Reported Adverse Reactions

DRUG INEFFECTIVE
1,884
DRY SKIN
1,504
ACNE
1,471
ERYTHEMA
1,155
SKIN BURNING SENSATION
974
SKIN IRRITATION
866
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION
624
SKIN EXFOLIATION
561
PRURITUS
495
OVERDOSE
490
RASH
472
HYPERSENSITIVITY
321
PAIN OF SKIN
320
SWELLING FACE
264
UNDERDOSE
198
URTICARIA
197
CONDITION AGGRAVATED
189
PRODUCT USE IN UNAPPROVED INDICATION
151
EYE SWELLING
150
DYSPNOEA
136

Who Reports Side Effects

Gender Distribution

Female 4,474 (77%)
Male 1,306 (23%)
Unknown 11

Age Distribution

0-17 1,118 (30%)
18-44 1,995 (54%)
45-64 409 (11%)
65-74 106 (3%)
75+ 38 (1%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 51 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
CEREBRAL ISCHAEMIA 11
DEATH 11
EMBOLISM 11
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 11
PNEUMONIA 8
PANCREATIC CARCINOMA 7
PAIN 6
DYSPNOEA 5
NEOPLASM PROGRESSION 5
COMPLETED SUICIDE 4
ACUTE RESPIRATORY FAILURE 3
ASTHENIA 3
DIARRHOEA 3
FATIGUE 3
INFECTION 3
OFF LABEL USE 3
TOXICITY TO VARIOUS AGENTS 3
WOUND 3
ACUTE KIDNEY INJURY 2
ACUTE MYELOID LEUKAEMIA 2

Reactions in Hospitalization Reports

Top reactions in 370 reports where hospitalization was an outcome.

Reaction Reports
SWELLING FACE 35
PAIN 34
HYPERSENSITIVITY 26
DYSPNOEA 25
PRURITUS 23
DRUG INEFFECTIVE 22
NAUSEA 21
FATIGUE 20
ANXIETY 19
DIARRHOEA 18
ERYTHEMA 17
OFF LABEL USE 17
RASH 17
EYE SWELLING 16
PNEUMONIA 16
PRODUCT USE IN UNAPPROVED INDICATION 16
CHEST PAIN 15
HEADACHE 15
VOMITING 15
ACUTE RESPIRATORY FAILURE 14

Nearby — Related Medications

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What the FAERS Data Reveals About benzoyl peroxide Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 6,624 voluntary reports linked to benzoyl peroxide and its brand equivalents (Benzac, PanOxyl), spanning 2004 through 2025. Of those, 51 (0.8%) listed death as an outcome and 370 (5.6%) involved hospitalization. The most common indication reported alongside adverse events was Acne.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 77% were female and 23% male; age distribution skews toward 18-44, with 1,995 reports in that bracket. The single most reported reaction is drug ineffective with 1,884 submissions, followed by dry skin and acne.

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.