Trifarotene Topical
Trifarotene is a topical retinoid used to treat acne vulgaris in people aged 9 and older.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Trifarotene Topical: Patient Information Guide
A plain-language walkthrough of Trifarotene Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Trifarotene topical is a retinoid used to treat acne vulgaris.
- Aklief Cream is approved for the topical treatment of acne vulgaris on the face and/or trunk in patients 9 years of age and older
⚙️How it works▾
Trifarotene is a retinoid — a relative of vitamin A — that works by activating proteins in skin cells called retinoic acid receptors (RAR), particularly the gamma subtype. Activating these receptors changes how skin cells develop and helps calm the inflammation that makes acne worse. While the exact chain of events that clears acne isn't fully mapped out, this receptor activity is what drives the drug's effect.
💊How it's taken▾
Aklief Cream is applied once daily in the evening to clean, dry skin. One pump covers the face; two pumps cover the upper trunk (chest, shoulders, reachable upper back); one more pump can be used for mid and lower back if needed. A moisturizer should be used regularly from the start of treatment to help manage skin dryness and irritation.
- Apply a thin layer only — more is not better
- Keep it away from eyes, lips, corners of the nose, and mucous membranes
- For skin use only — not to be swallowed, used in the eyes, or used vaginally
🤒Side effects — in detail▾
The most common side effects of Aklief Cream are related to skin irritation at the site where you apply it.
- Skin irritation at the application site (7.5% of users in trials)
- Itching at the application site (2.4%)
- Sunburn — your skin is more sun-sensitive during treatment (2.6%)
- Redness, scaling, dryness, stinging, or burning — especially in the first 4 weeks
If irritation becomes severe or doesn't ease up after the early weeks of treatment, contact your doctor — you may need to use the cream less often or take a break from it.
⚠️Warnings & precautions▾
- Skin irritation: Redness, peeling, dryness, and stinging are common and tend to peak in the first 4 weeks. Use a moisturizer from day one. Don't apply to cuts, broken skin, eczema, or sunburned skin, and avoid waxing treated areas.
- Sun sensitivity: Aklief Cream makes skin more sensitive to UV light — including sunlight and tanning lamps. Use sunscreen and protective clothing on treated areas when going outdoors. People who already burn easily need to be especially careful.
🔀What it interacts with▾
Aklief Cream has very low systemic absorption, so drug interactions are not a major concern. However, here's what the label notes:
- Topical use of Aklief Cream is not expected to reduce the effectiveness of birth control pills containing ethinyl estradiol and levonorgestrel
- No clinically significant interaction is expected with fluconazole (a common antifungal), based on modeling studies
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Animal studies showed serious fetal harm at very high oral doses; discuss with your doctor if you are pregnant or planning to become pregnant
- Breastfeeding: It is unknown whether trifarotene passes into human milk; if breastfeeding, apply to the smallest skin area for the shortest time, and never apply to the nipple or areola
- Children under 9: Safety and effectiveness have not been established in this age group
- Adults 65 and older: Clinical trials did not include this age group, so it is unknown if older adults respond differently
- Sensitive or damaged skin: Do not apply to cuts, open sores, eczema, or sunburned skin
- High sun exposure: Tell your doctor if you spend a lot of time outdoors or are naturally sun-sensitive
📡Pharmacodynamics — effects in the body▾
At the recommended topical dose, Aklief Cream does not cause a clinically meaningful change in heart rhythm (it does not prolong the QT interval — the electrical recovery time of the heart between beats). Systemic absorption through the skin is very low, which limits the drug's effects on the rest of the body.
🔬Pharmacokinetics — how your body processes it▾
When Aklief Cream is applied daily to the face and trunk, only very small amounts reach the bloodstream — and blood levels were too low to measure in roughly two-thirds of study participants. Steady-state levels in the blood are reached after about 2 weeks, and the drug does not build up in the body with long-term use. In the body, trifarotene is broken down mainly by liver enzymes (CYP2C9, CYP3A4, CYP2C8) and cleared primarily through the feces, with a half-life of 2 to 9 hours.
📦How to store it▾
Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted to 15° to 30°C (59° to 86°F). Keep away from heat. Keep out of reach of children.
📄 Written from Trifarotene Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Trifarotene Topical
3 supplements and herbal products have documented interactions with Trifarotene Topical in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 2
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Trifarotene Topical — the kind of thing our pharmacy team would talk through with you at the counter.
What is Aklief Cream actually used for? ▾
How do I apply it, and when should I use it? ▾
My skin feels dry and irritated — is that normal? ▾
Do I need to worry about the sun while using this cream? ▾
Can I use this if I'm pregnant or breastfeeding? ▾
Will it interfere with my birth control pill? ▾
Is Trifarotene Topical available over the counter? ▾
When was Trifarotene Topical first available? ▾
💬 Answers drafted from Trifarotene Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Trifarotene Topical comes
Trifarotene Topical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Topical cream, ointment or gel
How this form is used
- Aklief Cream is used for the topical treatment of acne vulgaris in patients 9 years of age and older
- Aklief Cream is approved for acne on the face and/or trunk (chest, shoulders, upper and lower back)
- Aklief Cream: apply a thin layer to affected areas once daily in the evening on clean, dry skin
- Aklief Cream: one pump actuation covers the face; two pump actuations cover the upper trunk; one additional actuation may be used for mid and lower back if acne is present
- Aklief Cream: use a moisturizer as frequently as needed starting from the first day of treatment
- Aklief Cream: avoid contact with eyes, lips, corners of the nose, and mucous membranes
📊 Trifarotene Topical across the U.S. market
How Trifarotene Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
📈 How widely Trifarotene Topical is used
A general measure of how commonly Trifarotene Topical is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Trifarotene Topical is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Trifarotene Topical prescribed? Of the 1,596 medications we measure, Trifarotene Topical ranks #1,124 by Medicaid prescriptions — more than 30% of them.
Utilization by Trifarotene Topical product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
trifarotene 0.05 MG/ML Topical Cream
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2205642
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Trifarotene Topical, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 4 listed Trifarotene Topical NDCs with Medicaid activity.
🔍 Compare Trifarotene Topical products
A representative set of FDA-listed product records for Trifarotene Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Topical cream, ointment or gel | ||||
| 50 mcg/g | Topical | Galderma Laboratories, L.P. × 3 listings | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Trifarotene Topical NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Trifarotene Topical — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Trifarotene Topical in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Trifarotene Topical went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2205637 1 dose form · 1 strength
-
Dose form (SCDF) Topical Cream RxCUI 2205641In current FDA listingsClinical drug / strength (SCD) 0.05 MG/MLRxCUI 2205642
Look up RxCUI 2205637 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Trifarotene Topical is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Trifarotene Topical belongs to the Retinoid class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Galderma Laboratories, L.P. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.