What the label lists and what reports show
Adapalene side effects
Adapalene's FDA label: “The most frequently reported (≥ 1%) adverse reactions were erythema, scaling, dryness, and/or burning/stinging.” FAERS holds 181,062 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 dry skin (45,427 reports).
- Generic listed
Check it at the source: the adapalene FDA label on DailyMed (effective December 27, 2023, 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 DIFFERIN Gel?DIFFERIN Gel may cause serious side effects including: Allergic reactions. DIFFERIN Gel may cause serious allergic reactions that sometimes may require medical treatment. Stop using DIFFERIN Gel and tell your healthcare provider or get medical help right away if you have any of these symptoms of an allergic reaction: skin rash, itching or hives trouble breathing or chest pain swelling of your face, eyes, lips, tongue, or throat Skin reactions at the treated site. DIFFERIN Gel may cause skin reactions including redness, scaling, dryness, stinging, and burning. These skin reactions are most likely to happen during the first 4 weeks of treatment, and usually lessen with continued use of DIFFERIN Gel. Your healthcare provider may tell you to use a moisturizer, decrease how often you use DIFFERIN Gel, or stop treatment with DIFFERIN Gel if you get any skin reactions. […]
Source: FDA drug label, Galderma Laboratories, L.P., effective December 27, 2023 (SPL set a0031324-92a6-4c11-90e2-c2818f7278ec), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most frequently reported (≥ 1%) adverse reactions were erythema, scaling, dryness, and/or burning/stinging.
Table 1: Physician assessed local cutaneous irritation with DIFFERIN Gel
| Reaction | Mild | Moderate | Severe |
|---|---|---|---|
| Erythema | 66 (26.1%) | 33 (13.0%) | 1 (0.4%) |
| Scaling | 110 (43.5%) | 47 (18.6%) | 3 (1.2%) |
| Dryness | 113 (44.7%) | 43 (17.0%) | 2 (0.8%) |
| Burning/Stinging | 72 (28.5%) | 36 (14.2%) | 9 (3.6%) |
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 frequently reported (≥ 1%) adverse reactions were erythema, scaling, dryness, and/or burning/stinging. ( 6.1 ) 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 Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne subjects who used DIFFERIN Gel once daily for 12 weeks. Of the subjects who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter.
Source: FDA drug label, Galderma Laboratories, L.P., effective December 27, 2023 (SPL set a0031324-92a6-4c11-90e2-c2818f7278ec), via openFDA; the full label on DailyMed
What do FAERS reports show?
181,062 reports list adapalene among the medicines taken, each a report of something that happened, not proof the medicine caused it; 33 are coded as a death and 359 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. Reports rose sharply in 2020 (58,491, against a median of 4,124 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 18 reactions below, 5 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.
Reports received each year
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: 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