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Zoryve

roflumilast
Used for Eczema, Plaque Psoriasis, Seborrheic Dermatitis
Used for Eczema, Plaque Psoriasis, Seborrheic Dermatitis

Zoryve (roflumilast) is a cream and foam that's approved for treating certain skin conditions in adults and children. The 0.15% cream is used to treat eczema and the 0.3% cream is used to treat plaque psoriasis. The 0.3% foam is approved for seborrheic dermatitis. Zoryve (roflumilast) is a phosphodiesterase 4 (PDE4) inhibitor. It's thought to lessen inflammation on the skin by lowering the activity of a protein in the body called PDE4. Zoryve (roflumilast) is applied to the affected area(s) on the skin once a day. Side effects can include pain where you apply the medication and headache.

Reviewed by:
reviewer
Kristianne Hannemann, PharmD
reviewer
Allison Gourley, PharmD
Last reviewed on July 14, 2024
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageCostContraindicationsAlternativesReferencesPricesMedicare
basics-icon

What is Zoryve (roflumilast)?

What is Zoryve (roflumilast) used for?

  • Mild-to-moderate eczema in people 6 years and older - 0.15% cream only

  • Plaque psoriasis in people 6 years and older - 0.3% cream only

  • Seborrheic dermatitis in people 9 years and older - 0.3% foam only

How Zoryve (roflumilast) works

Zoryve (roflumilast) is a phosphodiesterase 4 (PDE4) inhibitor. It blocks a protein in the body called PDE4. This protein plays a role in causing inflammation in your body.

By blocking PDE4, Zoryve (roflumilast) lowers the protein's ability to cause inflammation. This is thought to help relieve signs and symptoms of plaque psoriasis, eczema, and seborrheic dermatitis.

Are you looking for information on Daliresp (roflumilast) instead?

Drug Facts

Common BrandsZoryve
Drug ClassPDE4 inhibitor
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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Avg retail price
$1107.45(save 22.19%)
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What are the side effects of Zoryve (roflumilast)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

Zoryve (roflumilast) 0.15% cream:
  • Headache (3%)
  • Nausea (2%)
Zoryve (roflumilast) 0.30% cream:
  • Diarrhea (3%)
  • Headache (2%)
Zoryve (roflumilast) 0.30% foam:
  • Nose and throat inflammation (2%)
  • Headache (1%)

Other Side Effects

  • Skin pain where the medication is applied
  • Trouble sleeping

Source: DailyMed

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

pros-and-cons

Pros and cons of Zoryve (roflumilast)

thumbs-up

Pros

Steroid-free topical medication

Only applied once a day, so it's convenient for most people

Generally safe to use for a long period of time

Few side effects

thumbs-down

Cons

Not safe for people with moderate-to-severe liver conditions

Not approved for children under 6 years old with plaque psoriasis or eczema or for children under 9 years old with seborrheic dermatitis

No lower-cost generic available; brand-name medication only

pharmacist-tips

Pharmacist tips for Zoryve (roflumilast)

pharmacist

  • For Zoryve (roflumilast) foam: Shake the can each time before you use it. Also, avoid placing the can near fire or lit cigarettes when you're applying the medication or right afterwards. The foam is flammable.

    • Only apply Zoryve (roflumilast) onto the outside of your body (e.g., the skin). Never place it in your eyes, nose, mouth, vagina, or ears.

      • Try to apply Zoryve (roflumilast) around the same time every day. Pick a time that's easy for you to remember, such as before bedtime or first thing in the morning.

        • Wash your hands after you apply Zoryve (roflumilast), unless you need to use the medication to treat the skin condition on your hands. Washing your hands afterwards can help prevent you from getting the medication in your eyes or mouth.

          • Tell your prescriber or pharmacist about what medications you're taking or planning to take. These include prescription medications, over-the-counter products, and supplements. Your care team can check for possible drug interactions with Zoryve (roflumilast). For example, the levels of Zoryve (roflumilast) in the body can rise if you also take ketoconazole or erythromycin. This can raise your risk for side effects.

            • Discuss the risks and benefits of using Zoryve (roflumilast) with your prescriber if you're pregnant or breastfeeding. There isn't enough information to know whether it's safe for you or your baby.

              • If a healthcare professional says it's okay to use Zoryve (roflumilast) while you're breastfeeding, apply the medication to the smallest area of skin for the shortest time needed. Don't apply Zoryve (roflumilast) directly to the nipple area or any area of your skin that could touch your baby's skin.

                • Store Zoryve (roflumilast) at room temperature and keep it out of reach of children and pets.

                  faqs

                  Frequently asked questions about Zoryve (roflumilast)

                  Is Zoryve (roflumilast) a steroid?
                  No, Zoryve (roflumilast) isn't a steroid. This medication belongs to a different class of medications called PDE4 inhibitors. Like steroids, Zoryve (roflumilast) helps lessen skin inflammation, but it works differently. Zoryve (roflumilast) also causes different side effects than topical steroids. Studies show that it's generally safe to use Zoryve (roflumilast) for long-term treatment. On the other hand, it's generally recommended to use topical steroids only for a few weeks at a time to avoid skin thinning and other side effects. Talk with your dermatologist to determine which medication is best for you.
                  How well does Zoryve (roflumilast) work for plaque psoriasis?
                  In clinical studies, about 40% of people with plaque psoriasis had clear or almost clear skin after they used the 0.30% Zoryve (roflumilast) cream every day for 8 weeks. Ask your dermatologist for more information if you have any questions about Zoryve (roflumilast).
                  Does Zoryve (roflumilast) work for eczema?
                  Yes, the FDA recently approved the 0.15% strength of the Zoryve (roflumilast) cream for eczema in people 6 years of age and older. This approval is based on findings from studies that showed that the medication works well to improve symptoms of eczema. About 30% of people with eczema had clear or almost clear skin after they used the 0.15% Zoryve (roflumilast) cream every day for 4 weeks.
                  How well does Zoryve (roflumilast) work for seborrheic dermatitis?
                  In a clinical study, almost 80% of people with seborrheic dermatitis had clear or almost clear skin after they used the 0.3% Zoryve (roflumilast) foam every day for 8 weeks. Discuss with your dermatologist to learn more about Zoryve (roflumilast).
                  Can you use Zoryve (roflumilast) on the face?
                  There's some evidence that Zoryve (roflumilast) is safe to use on the face. One study showed that using Zoryve (roflumilast) on the face didn't cause worrisome side effects that steroids sometimes cause, such as thinning of the skin. But in general, you should avoid getting Zoryve (roflumilast) in your eyes, nose, and mouth to prevent irritation. Ask your dermatologist if you have questions on where you should apply Zoryve (roflumilast).
                  How long does it take for Zoryve (roflumilast) to work?
                  The time it will take for Zoryve (roflumilast) to work is different for everyone. For plaque psoriasis and seborrheic dermatitis, you might start to notice improvement in your symptoms within the first 2 weeks after you start treatment. For eczema, some people who participated in clinical studies reported improvement in itch as early as a day after they started using Zoryve (roflumilast). Keep in mind that it can take a few months or longer for you to see the full effects of the medication. Talk to your dermatologist if you don't notice any symptom relief within the first few weeks of starting Zoryve (roflumilast).
                  Is Zoryve (roflumilast) a biologic?
                  No, Zoryve (roflumilast) isn't a biologic. A biologic is a medication that comes from a living source, such as proteins. Instead, Zoryve (roflumilast) is a chemical that's made in a laboratory.
                  What's the difference between Zoryve and Vtama?
                  Zoryve (roflumilast) and Vtama (tapinarof) both help treat plaque psoriasis. They both come as a cream that's applied once daily to the affected area(s). But Zoryve and Vtama work differently to treat plaque psoriasis. They're also approved for use in different age groups. Vtama is only approved for adults, whereas Zoryve can be used for people 6 years and older. Additionally, there are other strengths and formulations of Zoryve that are approved for other skin conditions (eczema and seborrheic dermatitis). Follow up with your dermatologist to learn more about comparing between Zoryve and Vtama.
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                  What are the risks and warnings for Zoryve (roflumilast)?

                  Zoryve (roflumilast) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

                  risk-warning

                  Flammable (foam only)

                  The foam version of Zoryve (roflumilast) is flammable and it can catch on fire easily. Keep the foam can away from flames or lit cigarettes while you're applying Zoryve (roflumilast) and also right after you apply the medication onto your skin.

                  dosage

                  Zoryve (roflumilast) dosage forms

                  The average cost for 1 tube of 60g of 0.3% of Zoryve (roflumilast) is $865.22 with a free GoodRx coupon. This is 21.87% off the average retail price of $1107.45.
                  can of foam
                  Can of foam
                  DosageQuantityPrice as low asPrice per unit
                  60g of 0.3%1 can$861.67$861.67
                  tube of cream
                  Tube of cream
                  DosageQuantityPrice as low asPrice per unit
                  60g of 0.15%1 tube$904.10$904.10
                  60g of 0.3%1 tube$865.22$865.22

                  Typical dosing for Zoryve (roflumilast)

                  Apply a thin layer to the affected area(s) on the skin once daily and rub the medication in completely.

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                  How much does Zoryve (roflumilast) cost?

                  To access savings, use a GoodRx coupon and pay just a fraction of the retail price.
                  Zoryve (brand)
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                  contraindications-icon

                  Zoryve (roflumilast) contraindications

                  Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Zoryve (roflumilast) will not be safe for you to take.

                  • Moderate-to-severe liver problems

                  alternatives

                  What are alternatives to Zoryve (roflumilast)?

                  There are a number of medications that your doctor can prescribe in place of Zoryve (roflumilast). Compare a few possible alternatives below.
                  Zoryve (roflumilast)
                  Used for:

                  • Mild-to-moderate eczema in people 6 years and older - 0.15% cream only

                  • Plaque psoriasis in people 6 years and older - 0.3% cream only

                  • Seborrheic dermatitis in people 9 years and older - 0.3% foam only

                  $861.67 Lowest GoodRx priceView Prices
                  Tacrolimus (Protopic)
                  Used for:

                  • Moderate-to-severe eczema in adults and children ages 2 years and older

                  $40.00 Lowest GoodRx priceView Prices
                  Calcipotriene
                  Used for:
                  $55.00 Lowest GoodRx priceView Prices

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                  References

                  Best studies we found

                  Arcutis Biotherapeutics, Inc. (2023). Zoryve- roflumilast aerosol, foam [package insert]. DailyMed.

                  Arcutis Biotherapeutics, Inc. (2024). FDA approves Arcutis’ Zoryve® (roflumilast) cream 0.15% for the treatment of atopic dermatitis in adults and children down to 6 years of age. Globe Newswire.

                  Arcutis Biotherapeutics, Inc. (2024). Zoryve- roflumilast cream [package insert]. DailyMed.

                  View All References (9)

                  Blauvelt, A., et al. (2024). Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: A randomized, double-blinded, vehicle-controlled, phase 3 trial. Journal of the American Academy of Dermatology.

                  Draelos, Z. D., et al. (2023). Efficacy and safety of roflumilast cream for chronic plaque psoriasis with facial/neck and intertriginous area involvement: A post hoc analysis from a randomized controlled trial. British Journal of Dermatology.

                  Eichenfield, L., et al. (2023). Once-daily roflumilast cream 0.15% for atopic dermatitis: Pooled results: From INTEGUMENT 1/2 phase 3 trials. Annals of Allergy, Asthma & Immunology.

                  Lebwohl, M., et al. (2022). Effect of roflumilast cream vs vehicle cream on chronic plaque psoriasis. Journal of the American Medical Association.

                  Lebwohl, M., et al. (2023). Durability of efficacy and safety of roflumilast cream 0.3% in adults with chronic plaque psoriasis from a 52-week, phase 2 open-label safety trial. Skin.

                  Li, B. S., et al. (2019). Should we instruct patients to rub topical agents into skin? The evidence. The Journal of Dermatological Treatment.

                  Ludmann, P. (2022). Seborrheic dermatitis: Overview.

                  Milakovic, M., et al. (2021). Phosphodiesterase-4 inhibition in psoriasis. Psoriasis.

                  Stein Gold, L., et al. (2024). Long-term safety and effectiveness of roflumilast cream 0.3% in adults with chronic plaque psoriasis: A 52-week, phase 2, open-label trial. Journal of the American Academy of Dermatology.

                  GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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