Over-the-counter medication · Antimicrobial (Topical)
benzoyl peroxide
Also sold as Benzac, PanOxyl. This medicine treats acne.
Data updated 2026-05-15
- 6,624
- FDA reportsLightly reported
- 2
- InteractionsFew interactions
- 10
- Recall records
What the data shows
benzoyl peroxide (Benzac) is an over-the-counter Antimicrobial (Topical), reported less often than most tracked drugs (6,624 FDA reports), with 2 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
benzoyl peroxide (Benzac) is an over-the-counter Antimicrobial (Topical). This medicine treats acne.
Benzoyl peroxide is a topical medicine that fights germs on your skin. It helps to clear up acne.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.16/unit
Generic Available
Yes (0 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats acne.
Common side effects
Dry skin, Acne, Skin irritation
Key warnings
If you develop a serious allergic reaction (hypersensitivity) such as swelling of the face, eyes, or difficulty breathing, stop using this product and seek immediate medical attention.
The sections below are summarized in plain English from benzoyl peroxide's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Benzoyl peroxide is an antimicrobial. This means it helps to kill germs on your skin that can cause acne. This reduces inflammation and clears pores.
Side Effects (from patient reports)
Based on 6,624 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for benzoyl peroxide, by number of reports
- Dry Skin
Dry Skin
1,504 reports
- Acne
Acne
1,471 reports
- Erythema
Erythema
1,155 reports
- Skin Burning Sensation
Skin Burning Sensation
974 reports
- Skin Irritation
Skin Irritation
866 reports
- Inappropriate Schedule Of Product Administration
Inappropriate Schedule Of Product Administration
624 reports
- Skin Exfoliation 561
Skin Exfoliation
561 reports
- Pruritus 495
Pruritus
495 reports
- Overdose 490
Overdose
490 reports
- Rash 472
Rash
472 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for benzoyl peroxide each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where benzoyl peroxide sits
benzoyl peroxide has more FDA adverse-event reports than 30% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is benzoyl peroxide; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 6,624 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
6,624
Reports Mentioning Death
51
0.8% of reports — not proof of cause
Hospitalization Reports
370
Top Indication
Acne
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | DRY SKIN | 1,504 |
| 3 | ACNE | 1,471 |
| 4 | ERYTHEMA | 1,155 |
| 5 | SKIN BURNING SENSATION | 974 |
| 6 | SKIN IRRITATION | 866 |
| 7 | INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION | 624 |
| 8 | SKIN EXFOLIATION | 561 |
| 9 | PRURITUS | 495 |
| 10 | OVERDOSE | 490 |
| 11 | RASH | 472 |
| 12 | HYPERSENSITIVITY | 321 |
| 13 | PAIN OF SKIN | 320 |
| 14 | SWELLING FACE | 264 |
| 15 | UNDERDOSE | 198 |
| 16 | URTICARIA | 197 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
If you develop a serious allergic reaction (hypersensitivity) such as swelling of the face, eyes, or difficulty breathing, stop using this product and seek immediate medical attention.
Known Drug Interactions
No formal drug-drug interaction studies were conducted with adapalene and benzoyl peroxide gel 0.1% / 2.5%.
Mechanism: There are no known studies showing that these two skin treatments interfere with each other.
Topical benzoyl peroxide used at the same time as ACZONE Gel, 7.5% may result in temporary local yellow or orange skin discoloration ( 7.2 ). 7.2 Topical Benzoyl Peroxide Topical application of dapsone gel followed by benzoyl peroxide in patients with acne vulgaris may result in a temporary local yellow or orange discoloration of the skin and facial hair.
Mechanism: These two skin treatments can react with each other on your skin to cause a temporary yellow or orange stain.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I use this all over my body?
How long will it take to see results?
Can I use other acne treatments with this?
What should I do if my skin gets too dry?
Can I use this if I have sensitive skin?
Will this bleach my clothes?
Can I go in the sun after using this?
What do I do if I get it in my eyes?
Is it okay to use if my skin is peeling?
How often should I use this?
What are the common side effects of benzoyl peroxide?
Does benzoyl peroxide interact with other medications?
What drug class is benzoyl peroxide?
What pregnancy or breastfeeding source fields are listed for benzoyl peroxide?
Has benzoyl peroxide been recalled?
Active Recalls
Chemical contamination: Presence of benzene
Owen Biosciences Inc.
Chemical contamination: Presence of benzene
Owen Biosciences Inc.
Chemical contamination: Presence of benzene
Owen Biosciences Inc.
Chemical contamination: Presence of benzene
Owen Biosciences Inc.
CGMP Deviations
CA BOTANA International, Inc.
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Private Label Skin Care Inc.
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Private Label Skin Care Inc.
Chemical contamination: presence of benzene
Fruit Of The Earth, Inc.
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
L'Oreal USA
Chemical Contamination: Presence of benzene.
Denison Pharmaceuticals, LLC
Related Medications in Antimicrobial (Topical)
Other drugs grouped near benzoyl peroxide - same-class peers and common alternatives.
adapalene
Differin
Compare with benzoyl peroxide →
apremilast
Otezla
Apremilast (Otezla/Otezla XR) is a medicine that can help adults and children manage psoriatic arthritis and psoriasis.
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azelaic acid
Finacea, Azelex
Azelaic acid gel is a topical medicine that helps treat rosacea.
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betamethasone
Diprosone, Luxiq
Betamethasone dipropionate cream is a strong steroid medicine used on the skin.
Compare with benzoyl peroxide →
brodalumab
Siliq
Siliq is a medicine used to treat moderate to severe plaque psoriasis.
Compare with benzoyl peroxide →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for benzoyl peroxide: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 6,624.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 0.77%.
- bempedoic acid Δ 0.03 pts · 2,157 reports · ACL Inhibitor 0.74%death share
- dexmethylphenidate Δ 0.11 pts · 4,083 reports · CNS Stimulant 0.88%death share
- tirzepatide Δ 0.23 pts · 120,921 reports · Dual GIP/GLP-1 Receptor Agonist 0.54%death share
- minoxidil Δ 0.24 pts · 43,650 reports · Vasodilator 1.01%death share
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Dangerous medication combinations and how to protect yourself
What the FDA Data Shows for benzoyl peroxide
The FDA label for benzoyl peroxide (sold under brand names such as Benzac, PanOxyl) classifies it as an over-the-counter product in the Antimicrobial (Topical) class. This medicine treats acne. Official labeling lists 6 commonly reported side effects, including Dry skin, Acne, Skin irritation.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 6,624 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.16.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 10 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: June 11, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages