What the label lists and what reports show
Adapalene and benzoyl peroxide side effects
Adapalene and benzoyl peroxide's FDA label: “The most common adverse reactions (incidence ≥1%) are skin irritation, eczema, atopic dermatitis and skin burning sensation.” FAERS holds 418 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is skin burning sensation (80 reports).
- Generic listed
Check it at the source: the adapalene and benzoyl peroxide FDA label on DailyMed (effective October 24, 2024, Galderma Laboratories, L.P.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of EPIDUO FORTE?EPIDUO FORTE may cause serious side effects including: Allergic reactions. Stop using EPIDUO FORTE and get medical help right away if you have any of the following symptoms during treatment with EPIDUO FORTE: hives, rash or severe itching swelling of your face, eyes, lips, tongue, or throat trouble breathing or throat tightness feeling faint, dizzy, or lightheaded Skin irritation. Skin irritation is common with EPIDUO FORTE and is most likely to happen during the first 4 weeks of treatment, and usually lessen with continued use of EPIDUO FORTE. Skin reactions at the treatment area include redness, scaling, dryness, stinging, burning, itching and swelling. Tell your doctor if you get any skin reactions. Sensitivity to sunlight. See “What should I avoid while using EPIDUO FORTE?” These are not all of the possible side effects of EPIDUO FORTE. […]
Source: FDA drug label, Galderma Laboratories, L.P., effective October 24, 2024 (SPL set f4e5d381-098a-4c93-9ff0-002cae46daac), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence ≥1%) are skin irritation, eczema, atopic dermatitis and skin burning sensation.
Table 2. Incidence of Local Cutaneous Irritation in 12-week Clinical Trial in Subjects with Acne Vulgaris
| Reaction | Moderate | Severe | Moderate | Severe |
|---|---|---|---|---|
| Erythema | 20% | 1% | 4% | <1% |
| Scaling | 17% | 1% | 1% | <1% |
| Dryness | 15% | 2% | 3% | <1% |
| Stinging/Burning | 19% | 6% | 1% | 1% |
| Erythema | 15% | 1% | 2% | <1% |
| Scaling | 12% | <1% | 2% | 0% |
| Dryness | 13% | 1% | 2% | 0% |
| Stinging/Burning | 14% | 9% | 3% | 0% |
| Erythema | 6% | 1% | 1% | 0% |
| Scaling | 6% | 0% | 1% | 0% |
| Dryness | 4% | 1% | 1% | 0% |
| Stinging/Burning | 3% | 1% | 0% | 0% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reactions (incidence ≥1%) are skin irritation, eczema, atopic dermatitis and skin burning sensation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The following adverse reactions are discussed in greater detail elsewhere in the labeling: Hypersensitivity [ see Warnings and Precautions ( 5.1 ) ] Skin Irritation/Contact Dermatitis [ see Warnings and Precautions ( 5.3 ) ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. During the randomized, double-blind, vehicle- and active-controlled clinical trial, 217 subjects were exposed to EPIDUO FORTE. A total of 197 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks. Adverse reactions reported within 12 weeks of treatment in at least 1% of subjects treated with EPIDUO FORTE and for which the rate with EPIDUO FORTE exceeded the rate for the vehicle are presented in Table 1: Table 1.
Source: FDA drug label, Galderma Laboratories, L.P., effective October 24, 2024 (SPL set f4e5d381-098a-4c93-9ff0-002cae46daac), via openFDA; the full label on DailyMed
What do FAERS reports show?
418 reports list adapalene and benzoyl peroxide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 19 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Adapalene and benzoyl peroxide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions