What the label lists and what reports show
Trifarotene side effects
Trifarotene's FDA label: “Most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus, and sunburn ( 6 ).” FAERS holds 180 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 erythema (28 reports).
- No generic listed
Check it at the source: the trifarotene FDA label on DailyMed (effective September 16, 2024, Galderma Laboratories, L.P.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus, and sunburn ( 6 ).
Table 2. Application Site Tolerability Reactions at Any Post Baseline Visit
| Reaction | Mild | Moderate | Severe | Mild | Moderate | Severe |
|---|---|---|---|---|---|---|
| Erythema | 30.6% | 28.4% | 6.2% | 21% | 6.8% | 0.8% |
| Scaling | 37.5% | 27.1% | 4.9% | 23.7% | 5.9% | 0.3% |
| Dryness | 39% | 29.7% | 4.8% | 29.9% | 6.8% | 0.8% |
| Stinging/Burning | 35.6% | 20.6% | 5.9% | 15.9% | 3.8% | 0.5% |
| Erythema | 26.5% | 18.9% | 5.2% | 12.7% | 4.4% | 0.4% |
| Scaling | 29.7% | 13.7% | 1.7% | 13.2% | 2.6% | 0.1% |
| Dryness | 32.9% | 16.1% | 1.8% | 17.8% | 3.9% | 0.1% |
| Stinging/Burning | 26.1% | 10.9% | 4.3% | 9.2% | 2.2% | 0.5% |
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, continuedMost common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus, and sunburn ( 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 Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect rates observed in practice. In the three Phase 3 clinical trials, 1673 subjects with acne vulgaris on the face and trunk, 9 years and older were exposed to AKLIEF Cream. Of these, 1220 subjects were treated once daily for up to 12 weeks and 453 were treated once daily for up to 1 year. Adverse reactions reported in the 2 randomized, double-blind, vehicle-controlled 12-week clinical trials in ≥ 1.0% of subjects treated with AKLIEF Cream (and for which the rate exceeded the rate for vehicle), as well as the corresponding rates reported in subjects treated with the vehicle cream are presented in Table 1. Table 1.
Source: FDA drug label, Galderma Laboratories, L.P., effective September 16, 2024 (SPL set 62d910db-85a6-4696-b69b-4bd2f3080cfc), via openFDA; the full label on DailyMed
What do FAERS reports show?
180 reports list trifarotene among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 9 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 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.
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?
- Trifarotene: 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