BENZOYL PEROXIDE

N/A

Manufactured by Alchemee, LLC

15,861 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BENZOYL PEROXIDE

BENZOYL PEROXIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alchemee, LLC. The most commonly reported adverse reactions for BENZOYL PEROXIDE include DRUG INEFFECTIVE, DRY SKIN, ACNE, ERYTHEMA, SKIN BURNING SENSATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BENZOYL PEROXIDE.

Top Adverse Reactions

DRUG INEFFECTIVE1,884 reports
DRY SKIN1,504 reports
ACNE1,471 reports
ERYTHEMA1,155 reports
SKIN BURNING SENSATION974 reports
SKIN IRRITATION866 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION624 reports
SKIN EXFOLIATION561 reports
PRURITUS495 reports
OVERDOSE490 reports
RASH472 reports
HYPERSENSITIVITY321 reports
PAIN OF SKIN320 reports
SWELLING FACE264 reports
UNDERDOSE198 reports
URTICARIA197 reports
CONDITION AGGRAVATED188 reports
PRODUCT USE IN UNAPPROVED INDICATION151 reports
EYE SWELLING150 reports
DYSPNOEA136 reports
SENSITIVE SKIN126 reports
RASH PAPULAR118 reports
SKIN HYPERPIGMENTATION114 reports
RASH MACULAR92 reports
SKIN DISCOLOURATION88 reports
SKIN SWELLING88 reports
SEBORRHOEA86 reports
ACNE CYSTIC83 reports
SCAR80 reports
RASH ERYTHEMATOUS79 reports
PAIN78 reports
OFF LABEL USE75 reports
DERMATITIS74 reports
PRODUCT USE ISSUE74 reports
NAUSEA72 reports
FATIGUE68 reports
ANXIETY66 reports
CHEMICAL BURN OF SKIN60 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION57 reports
DEPRESSION55 reports
DIARRHOEA55 reports
BLISTER54 reports
HEADACHE52 reports
PARAESTHESIA52 reports
SKIN FISSURES52 reports
THROAT TIGHTNESS48 reports
DRUG HYPERSENSITIVITY47 reports
SKIN TIGHTNESS44 reports
BURNING SENSATION43 reports
LIP SWELLING43 reports
THERAPEUTIC PRODUCT EFFECT DECREASED42 reports
ARTHRALGIA41 reports
APPLICATION SITE ERYTHEMA38 reports
DIZZINESS38 reports
EYE IRRITATION38 reports
SKIN FRAGILITY36 reports
SWELLING36 reports
ECZEMA33 reports
VOMITING33 reports
DERMATITIS CONTACT31 reports
SKIN HAEMORRHAGE31 reports
PHARYNGEAL OEDEMA30 reports
PYREXIA30 reports
APPLICATION SITE PAIN29 reports
INSOMNIA29 reports
ANAPHYLACTIC REACTION28 reports
OCULAR HYPERAEMIA28 reports
PSORIASIS28 reports
SKIN DISCOMFORT28 reports
ABDOMINAL PAIN27 reports
ANGIOEDEMA27 reports
MALAISE27 reports
BACK PAIN26 reports
CHEST PAIN26 reports
APPLICATION SITE SWELLING25 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION25 reports
RASH PRURITIC25 reports
SCAB25 reports
CONSTIPATION24 reports
EMOTIONAL DISTRESS24 reports
SKIN HYPOPIGMENTATION24 reports
PRODUCT DOSE OMISSION ISSUE23 reports
ASTHENIA22 reports
FEELING HOT22 reports
SKIN INFECTION22 reports
COUGH21 reports
PNEUMONIA21 reports
WEIGHT DECREASED21 reports
DECREASED APPETITE20 reports
DYSPHAGIA20 reports
HYPOAESTHESIA20 reports
MYALGIA20 reports
SKIN REACTION20 reports
ABDOMINAL PAIN UPPER19 reports
ALOPECIA19 reports
ASTHMA19 reports
EXPOSURE DURING PREGNANCY19 reports
INJURY19 reports
PAIN IN EXTREMITY19 reports
TREATMENT FAILURE19 reports

Report Outcomes

Out of 6,623 classified reports for BENZOYL PEROXIDE:

Serious 20.8%Non-Serious 79.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female4,474 (77.3%)
Male1,306 (22.6%)
Unknown11 (0.2%)

Reports by Age

Age 15236 reports
Age 14231 reports
Age 16215 reports
Age 13175 reports
Age 17147 reports
Age 18147 reports
Age 19130 reports
Age 2095 reports
Age 2989 reports
Age 2488 reports
Age 2787 reports
Age 2386 reports
Age 1285 reports
Age 2885 reports
Age 3085 reports
Age 2183 reports
Age 2283 reports
Age 3183 reports
Age 2679 reports
Age 3479 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with BENZOYL PEROXIDE?

This profile reflects 15,861 FDA FAERS reports that mention BENZOYL PEROXIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BENZOYL PEROXIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DRY SKIN, ACNE, ERYTHEMA, SKIN BURNING SENSATION, SKIN IRRITATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BENZOYL PEROXIDE?

Labeling and FAERS entries often list Alchemee, LLC in connection with BENZOYL PEROXIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.