FDA-filed SPL labeling · retrieved through openFDA

Tapinarof Topical

Tapinarof is a topical skin treatment used for plaque psoriasis in adults and atopic dermatitis in adults and children 2 years and older.

Brand name Vtama
Drug class Aryl Hydrocarbon Receptor Agonist
Rx Form 1 Route Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 →

At a glance
Linked label effectiveMay 28, 2025
AvailabilityRx
Earliest approval/marketing year 2022
FDA-listed product records 4
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
Tapinarof Topical at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Vtama cream (tapinarof 1%) is a once-daily topical treatment for plaque psoriasis in adults and atopic dermatitis in adults and children 2 and older. The most common side effect is folliculitis — small, inflamed bumps around hair follicles — so let your doctor know if this becomes bothersome. It has no formal drug interaction concerns identified in lab studies, but always keep your healthcare team informed about your full health picture, especially if you are pregnant or breastfeeding.

📖 Tapinarof Topical: Patient Information Guide

A plain-language walkthrough of Tapinarof 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

Tapinarof topical is approved for two skin conditions, with product-specific and age-specific distinctions:

  • Plaque psoriasis — Vtama cream, 1% is approved for adults only. It has not been studied or approved for plaque psoriasis in children.
  • Atopic dermatitis (eczema) — Vtama cream, 1% is approved for adults and children 2 years of age and older. It has not been approved for children under 2 years old.
⚙️How it works

Tapinarof is an aryl hydrocarbon receptor (AhR) agonist — that means it binds to and activates a specific protein called the AhR found in skin cells. Activating this receptor is believed to help regulate the abnormal immune responses and skin cell behavior that cause conditions like psoriasis and eczema. The precise steps by which this leads to clearer, calmer skin are not yet fully understood.

💊How it's taken

Apply a thin layer of Vtama cream to the affected skin areas once daily. No food restrictions apply since this is a topical treatment. Wash your hands after applying unless your hands are the treatment area. Do not use it on the eyes, in the mouth, or vaginally — it is only for the skin. Always follow your prescriber's and the product label's instructions for how long to continue treatment.

🤒Side effects — in detail

The most common side effects vary slightly depending on the condition being treated:

  • Plaque psoriasis: folliculitis (inflamed hair follicles), nasopharyngitis (cold-like symptoms), contact dermatitis, headache, itching, and influenza-like illness
  • Atopic dermatitis: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in a limb, and abdominal pain
  • A small number of people developed hives (urticaria) during trials

Folliculitis and contact dermatitis were the most common reasons people stopped using Vtama cream in clinical trials. If you develop painful, spreading bumps at the application site or signs of an allergic reaction like hives, contact your doctor promptly.

⚠️Warnings & precautions
  • Folliculitis risk: About 20% of adults with plaque psoriasis and 9% of those with atopic dermatitis developed folliculitis (inflamed hair follicles) during trials — watch for small red or tender bumps at the application site.
  • Skin irritation: Contact dermatitis occurred in 7% of psoriasis patients; let your doctor know if irritation worsens.
  • Pregnancy: There is not enough human data to confirm safety in pregnancy. Animal studies at high doses showed some effects on fetal development. Discuss the risks and benefits with your doctor.
  • Breastfeeding: It is not known if tapinarof passes into human breast milk. Animal data suggest the drug can be present in milk. Talk to your doctor about whether to continue, pause, or adjust breastfeeding.
  • Children under 2 and pediatric psoriasis: Safety and effectiveness have not been established in children under 2 or in children with plaque psoriasis — do not use in these groups.
  • Eyes, mouth, vaginal use: Vtama cream is not intended for these areas — avoid contact.
🔀What it interacts with

Based on laboratory studies, tapinarof does not appear to meaningfully interact with most common drugs processed by the liver's enzyme systems:

  • Tapinarof does not inhibit or induce the major CYP liver enzymes (including CYP2C9, CYP2D6, CYP3A4, and others) — so it is unlikely to raise or lower levels of many common medications
  • Tapinarof does not affect major drug transporter proteins in the body

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
  • Pregnant or trying to conceive: Human safety data are limited — discuss with your doctor before starting Vtama cream
  • Breastfeeding: Unknown if tapinarof passes into human milk — weigh benefits and risks with your doctor
  • Children under 2: Vtama cream is not approved for this age group for any condition
  • Children with psoriasis: Vtama cream is not approved for plaque psoriasis in children of any age
  • Older adults (65+): No significant differences in safety or effectiveness were seen in clinical trials, but always inform your doctor of your complete health history
📡Pharmacodynamics — effects in the body

The pharmacodynamics of Vtama cream — meaning its measurable effects on the body — are not fully characterized. At the approved dosage, Vtama cream does not cause a clinically meaningful prolongation of the QTc interval (a measure of the heart's electrical timing), which is reassuring from a heart-safety standpoint.

🔬Pharmacokinetics — how your body processes it

Tapinarof is absorbed through the skin in relatively small amounts. In adults with plaque psoriasis, drug levels in the blood did not build up with repeated daily use, and the majority of blood samples in studies had no measurable drug at all. In children with atopic dermatitis, blood levels were somewhat higher than in adults, particularly in younger children (ages 2–6), likely because children often have a larger proportion of their body surface area affected. Once absorbed, tapinarof binds extensively to plasma proteins (about 99%) and is broken down by the liver through several pathways, including oxidation and conjugation reactions.

📦How to store it

- Store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15°C and 30°C (59°F and 86°F) . Do not freeze. Protect from exposure to excessive heat.

📄 Written from Tapinarof 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 →

3

Supplements & herbs that interact with Tapinarof Topical

3 supplements and herbal products have documented interactions with Tapinarof Topical in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 2
  • Minor · 1
Every supplement checked against Tapinarof Topical — ranked by severity The full interaction hub: 2 moderate · 1 minor · every one linked to its full report. Check Tapinarof Topical against your exact supplements

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 Tapinarof Topical — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Vtama cream used for?
Vtama cream treats two skin conditions: plaque psoriasis and atopic dermatitis (eczema). For psoriasis, it's approved for adults only. For atopic dermatitis, it can be used in adults and children as young as 2 years old. It's a once-daily cream applied right to the affected skin.
How do I apply it, and are there any special instructions?
Just apply a thin layer to your affected skin areas once a day. After you're done, wash your hands — unless of course your hands are the area you're treating. Keep it away from your eyes, mouth, and vaginal area. It's only meant for the skin.
What side effects should I watch out for?
The most common one is folliculitis — those are small, inflamed red bumps around your hair follicles where you apply the cream. It happened in about 1 in 5 adults using it for psoriasis. You might also notice cold-like symptoms, skin irritation, or headache. If the bumps become painful, spreading, or severe — or if you develop hives — let your doctor know, as those were reasons some people stopped using the cream in studies.
Will it interact with my other medications?
Based on lab studies, tapinarof doesn't appear to significantly interfere with the liver enzymes that process most common medications. That said, always let your doctor and pharmacist know everything you're taking — including over-the-counter products — just to be safe.
Is it safe to use if I'm pregnant or breastfeeding?
There isn't enough human data yet to say for certain that it's safe during pregnancy. Animal studies at very high doses showed some effects on fetal development. As for breastfeeding, it's not known whether tapinarof passes into human milk, though it was found in animal milk. Have a candid conversation with your doctor — they can help you weigh the benefits of treating your skin condition against any potential risks.
Can my child use Vtama cream?
It depends on the condition. For atopic dermatitis (eczema), Vtama cream is approved for children 2 years and older. For plaque psoriasis, it has not been studied in children, so it's not approved for that use in kids. If your child is under 2, Vtama cream is not approved for them regardless of the condition. Talk to your child's doctor if you have questions about the right treatment.
Is Tapinarof Topical available over the counter?
Tapinarof Topical is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Tapinarof Topical first available?
Tapinarof Topical has been available in the United States since at least 2022, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Tapinarof Topical?
Tapinarof Topical is supplied by 3 manufacturers listed in the FDA NDC Directory, including Dermavant Sciences, Inc., Organon LLC, ThermoFisher Scientific Cork.

💬 Answers drafted from Tapinarof 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 Tapinarof Topical comes

Tapinarof 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

By mouth · On the skin
Brands Vtama
How this form is used
What it may be used for
  • Vtama cream is used to treat plaque psoriasis in adults
  • Vtama cream is used to treat atopic dermatitis in adults and children 2 years of age and older
Important instructions
  • Vtama cream: apply a thin layer to affected skin areas once daily
  • Vtama cream: wash hands after applying, unless the hands are the area being treated
  • Vtama cream is for skin use only — do not use it in or around the eyes, mouth, or vaginal area
  • Vtama cream: follow your prescriber's guidance on which areas to treat and how long to continue
Available strengths 3 strengths
4 FDA-listed product records

📊 Tapinarof Topical across the U.S. market

How Tapinarof 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.

1
Dose forms
3
Manufacturers
1
Brand names
4
FDA-listed product records
2022
First marketed
Dermavant Sciences, Inc.50%
Organon LLC25%
ThermoFisher Scientific Cork25%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Tapinarof Topical is used

A general measure of how commonly Tapinarof 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 Tapinarof 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.

31,509
Medicaid prescriptions filled (Q1–Q4 2025)
$47.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tapinarof Topical prescribed? Of the 1,596 medications we measure, Tapinarof Topical ranks #729 by Medicaid prescriptions — more than 54% of them.

Where Tapinarof Topical ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Tapinarof 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.

tapinarof 10 MG/ML Topical Cream

31,509 Medicaid prescriptions (Q1–Q4 2025) 100% of Tapinarof Topical prescriptions shown $47.2M gross reimbursement (before rebates) ≈ $1,498 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2602301

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 Tapinarof 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 1 listed Tapinarof Topical NDCs with Medicaid activity.

🔍 Compare Tapinarof Topical products

A representative set of FDA-listed product records for Tapinarof 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
10 mg/1000 mg Topical Dermavant Sciences, Inc. NDA View NDC →
10 mg/g Topical Dermavant Sciences, Inc. NDA View NDC →
10 mg/g Topical Organon LLC NDA View NDC →
1 kg/kg ThermoFisher Scientific Cork BULK INGREDIENT View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Tapinarof Topical NDCs →

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.

Ingredient (IN) Tapinarof Topical RxCUI 2602286 1 dose form · 1 strength
  1. Dose form (SCDF) Topical Cream RxCUI 2602300 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 2602301

Look up RxCUI 2602286 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.

🏷️ Sold under these brand names

Vtama

🏭 Manufacturers & labelers

Dermavant Sciences, Inc. 2 Organon LLC 1 ThermoFisher Scientific Cork 1

RxNorm drug class

Tapinarof Topical belongs to the Aryl Hydrocarbon Receptor Agonist class.

Pharmacologic class Aryl Hydrocarbon Receptor Agonist
Drug family (ATC) Other antipsoriatics for topical use
How it works Aryl Hydrocarbon Receptor Agonists

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 28, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tapinarof Topical.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Tapinarof Topical after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
4
Distinct labelers/manufacturers represented
3
Linked representative label
Organon LLC
Linked label effective
May 28, 2025
Composite sections available
18
Linked SPL Set ID
9309d20f-8cd4-4c96-93fa-7f730e83c7ab
Linked SPL Document ID
4615ce09-cf4d-4410-91ff-db3caea7a802
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

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. Organon LLC 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.