ADAPALENE AND BENZOYL PEROXIDE

N/A

Manufactured by Galderma Laboratories, L.P.

3,122 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ADAPALENE AND BENZOYL PEROXIDE

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

Top Adverse Reactions

ERYTHEMA271 reports
SKIN BURNING SENSATION212 reports
DRY SKIN207 reports
DRUG INEFFECTIVE161 reports
ACNE146 reports
SKIN EXFOLIATION138 reports
PRURITUS133 reports
SWELLING FACE100 reports
SKIN IRRITATION96 reports
PAIN OF SKIN92 reports
RASH71 reports
HYPERSENSITIVITY55 reports
APPLICATION SITE ERYTHEMA38 reports
OFF LABEL USE37 reports
CONDITION AGGRAVATED32 reports
EYE SWELLING31 reports
HEADACHE31 reports
ANXIETY29 reports
PAIN28 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION27 reports
DERMATITIS26 reports
URTICARIA26 reports
NAUSEA25 reports
RASH PAPULAR25 reports
DEPRESSION24 reports
EYELID OEDEMA24 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION24 reports
SKIN HYPERPIGMENTATION24 reports
DERMATITIS ALLERGIC23 reports
DIZZINESS23 reports
DYSPNOEA23 reports
SKIN DISCOLOURATION23 reports
DRUG INTERACTION22 reports
SCAR22 reports
APPLICATION SITE PAIN20 reports
BLISTER20 reports
RASH MACULAR20 reports
SUICIDAL IDEATION20 reports
APPLICATION SITE PRURITUS19 reports
UNDERDOSE19 reports
APPLICATION SITE DRYNESS17 reports
DRUG EFFECT DECREASED17 reports
FATIGUE17 reports
SWELLING OF EYELID17 reports
BURNING SENSATION16 reports
EXPOSURE DURING PREGNANCY16 reports
SWELLING16 reports
DERMATITIS CONTACT15 reports
PARAESTHESIA15 reports
PRODUCT USE IN UNAPPROVED INDICATION15 reports
PYREXIA15 reports
RASH ERYTHEMATOUS15 reports
SEBORRHOEA15 reports
VISION BLURRED15 reports
ANGIOEDEMA14 reports
EMOTIONAL DISTRESS14 reports
SKIN WARM14 reports
APPLICATION SITE EXFOLIATION13 reports
ARTHRALGIA13 reports
CHEMICAL INJURY13 reports
ERYTHEMA OF EYELID13 reports
FEELING ABNORMAL13 reports
INTENTIONAL PRODUCT MISUSE13 reports
INTENTIONAL PRODUCT USE ISSUE13 reports
MIGRAINE13 reports
NASOPHARYNGITIS13 reports
DEPRESSED MOOD12 reports
MYALGIA12 reports
OBSESSIVE COMPULSIVE DISORDER12 reports
PRODUCT USE ISSUE12 reports
SCAB12 reports
SKIN SWELLING12 reports
ACNE CYSTIC11 reports
ALOPECIA11 reports
DERMATITIS ATOPIC11 reports
DIARRHOEA11 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION11 reports
DRY EYE11 reports
INSOMNIA11 reports
INTENTIONAL UNDERDOSE11 reports
OCULAR HYPERAEMIA11 reports
SKIN TIGHTNESS11 reports
THERAPEUTIC RESPONSE UNEXPECTED11 reports
CHEST PAIN10 reports
ECZEMA10 reports
FEELING HOT10 reports
PULMONARY EMBOLISM10 reports
SKIN FISSURES10 reports
SKIN HYPOPIGMENTATION10 reports
THROAT TIGHTNESS10 reports
VOMITING10 reports
WEIGHT DECREASED10 reports
APPLICATION SITE BURN9 reports
APPLICATION SITE SWELLING9 reports
CHEMICAL BURN OF SKIN9 reports
COUGH9 reports
FACE OEDEMA9 reports
NECK PAIN9 reports
OVERDOSE9 reports
PRE EXISTING CONDITION IMPROVED9 reports

Report Outcomes

Out of 1,392 classified reports for ADAPALENE AND BENZOYL PEROXIDE:

Serious 31.8%Non-Serious 68.2%

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

Female892 (70.1%)
Male366 (28.8%)
Unknown15 (1.2%)

Reports by Age

Age 1583 reports
Age 1674 reports
Age 1455 reports
Age 1750 reports
Age 1338 reports
Age 1837 reports
Age 1931 reports
Age 2031 reports
Age 3229 reports
Age 2328 reports
Age 2428 reports
Age 1227 reports
Age 2927 reports
Age 2226 reports
Age 3026 reports
Age 2525 reports
Age 2122 reports
Age 2817 reports
Age 3516 reports
Age 3616 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 ADAPALENE AND BENZOYL PEROXIDE?

This profile reflects 3,122 FDA FAERS reports that mention ADAPALENE AND BENZOYL PEROXIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ADAPALENE AND BENZOYL PEROXIDE?

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

Who manufactures ADAPALENE AND BENZOYL PEROXIDE?

Labeling and FAERS entries often list Galderma Laboratories, L.P. in connection with ADAPALENE AND 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.