Trifarotene: uses, dosing, side effects & brands
Trifarotene is a medicine sold in the U.S. under one brand, for acne vulgaris. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Acne Vulgaris
- Available as
- Topical
- Sold as
- Aklief
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
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How trifarotene is dosed
From the FDA label for Aklief (application NDA211527). Other trifarotene products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Apply a thin layer of AKLIEF Cream to the affected areas once daily, in the evening, on clean and dry skin. One pump actuation should be enough to cover the face (i.e., forehead, cheeks, nose, and chin). Two actuations of the pump should be enough to cover the upper trunk (i.e., reachable upper back, shoulders and chest). One additional pump actuation may be used for middle and lower back if acne is present. The use of a moisturizer is recommended as frequently as needed from the initiation of treatment. Avoid contact with the eyes, lips, paranasal creases, mucous membranes. AKLIEF Cream is for topical use only. Not for oral, ophthalmic, or intravaginal use. For topical use only. Not for oral, ophthalmic or intravaginal use. Apply a thin layer of AKLIEF Cream to the affected areas of the face and/or trunk once a day, in the evening, on clean and dry skin. Avoid contact with the eyes, lips, paranasal creases, and mucous membranes. ( 2 )
Trifarotene side effects
Most 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. Adverse Reactions Occurring in ≥ 1.0% of Subjects with Acne Vulgaris of the Face and Trunk in the Two 12-week Phase 3 Clinical Trials Preferred Term AKLIEF Cream (N=1220) Vehicle Cream (N=1200) Application…
Who shouldn’t take trifarotene
None None ( 4 )
Trifarotene drug interactions
Topical application of AKLIEF Cream is not expected to affect the circulating concentrations of oral hormonal contraceptives containing ethinyl estradiol and levonorgestrel.
Every trifarotene product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Aklief.
What people report to the FDA about trifarotene
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 25 reports naming trifarotene, and the FDA flagged 92% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- urinary retention16 reports
- mydriasis14 reports
- vision blurred8 reports
- abdominal distension2 reports
- adnexal torsion2 reports
- dysuria2 reports
- liver injury2 reports
- micturition urgency2 reports
Read these as a signal, not a rate. A report does not mean trifarotene caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is trifarotene?
AKLIEF Cream for topical administration contains 0.005% (50 mcg/g) trifarotene. Trifarotene is a terphenyl acid derivative and is a retinoid.
Can you take trifarotene with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run trifarotene against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does trifarotene come in?
Across the brands we track, trifarotene is currently marketed as topical, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic trifarotene?
We do not currently list a generic-labelled trifarotene product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Trifarotene: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/trifarotene
- MLA
- “Trifarotene: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/trifarotene.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for trifarotene on DailyMed (NIH) ↗.