Zoryve (roflumilast)

Zoryve generic

Zoryve is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

The active drug in Zoryve cream is roflumilast. This active drug is also available as an oral tablet. However, the oral form is not used to treat the same condition as Zoryve cream.

Zoryve side effects

Zoryve can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Zoryve. These lists do not include all possible side effects.

For more information about the possible side effects of Zoryve, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Zoryve, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Zoryve. To learn about other mild side effects, talk with your doctor or pharmacist, or view Zoryve’s prescribing information.

Mild side effects of Zoryve can include:

• diarrhea
• headache
• insomnia
• pain at application sites (the areas of your skin where you applied the drug)
• infection, such as upper respiratory infection or urinary tract infection
• mild allergic reaction*

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Zoryve, see “Allergic reaction” below.

Serious side effects

Zoryve isn’t known to cause serious side effects. However, serious side effects, such as severe allergic reactions, may still occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Zoryve. This side effect wasn’t reported in clinical trials of Zoryve but can still occur.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Zoryve, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Zoryve uses

The Food and Drug Administration (FDA) approves prescription drugs such as Zoryve to treat certain conditions. Zoryve may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Zoryve for plaque psoriasis

Zoryve is FDA approved to treat plaque psoriasis of the skin and skin folds. It’s approved for this purpose in adults and children ages 12 years and older.

Psoriasis is a skin condition that causes patches of itchy, inflamed skin. These skin patches are known as plaques. Patches most commonly appear on the scalp, elbows, knees, and lower back.

Zoryve is a cream that you apply directly to plaques. It can be applied on skin folds (areas where your skin touches, such as between your fingers). However, Zoryve should not be used in the eyes, mouth, or vagina.

To learn more about treatments for plaque psoriasis, see our psoriasis hub.

Zoryve and children

Zoryve is FDA approved to treat plaque psoriasis in children ages 12 years and older. It isn’t known if the drug is safe or effective for younger children with plaque psoriasis.

Zoryve cost

As with all medications, the cost of Zoryve can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Drug coupons: You can visit Optum Perks* for price estimates of Zoryve. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.

Financial and insurance assistance: If you need financial support to pay for Zoryve, or if you need help understanding your insurance coverage, help is available.

A program called Zoryve Direct is available for Zoryve. For more information and to find out if you’re eligible for support, visit the program website.

To learn more about saving money on prescriptions, check out this article.

Generic version: Zoryve is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

* Optum Perks is a sister site of Medical News Today.

Similar drugs

Other drugs are available that can treat plaque psoriasis. Some may be a better fit for you than others. If you’re interested in finding an alternative to Zoryve, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are similar to Zoryve:

• other topical medications, such as:
  • tapinarof (Vtama)
  • calcipotriene (Dovonex, Sorilux)
  • halobetasol/tazarotene (Duobrii)
  • calcipotriene/betamethasone (Enstilar, Taclonex, Wynzora)
  • salicylic acid (Gold Bond Psoriasis Cream)
  • coal tar (Psoriasin)
  • tazarotene (Tazorac)
  • calcitriol (Vectical)
• oral medications, such as:
  • apremilast (Otezla)
  • methotrexate (Trexall)
  • acitretin
  • cyclosporine (Gengraf, Neoral, Sandimmune)
• injectable medications, such as:
  • adalimumab (Humira)
  • deucravacitinib (Sotyktu)
  • etanercept (Enbrel)
  • secukinumab (Cosentyx)
  • methotrexate (Otrexup, Rasuvo, Reditrex)
  • risankizumab-rzaa (Skyrizi)

Zoryve dosage

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Zoryve is a topical cream. It comes in one strength: 0.3%. Each gram of cream contains 3 milligrams of the drug.

Dosage for plaque psoriasis

To treat plaque psoriasis in adults, you should apply a thin layer of Zoryve cream to the psoriasis plaques once per day.

Children’s dosage

Children ages 12 years and older should apply a thin layer of Zoryve cream to the psoriasis plaques once per day. (The dosage is typically the same for children and adults.)

How to use

Zoryve is a topical cream that you apply directly to areas of your skin affected by plaque psoriasis. It can be applied to affected areas with skin folds (areas where your skin touches, such as between your fingers). However, Zoryve should not be used in the eyes, mouth, or vagina.

Be sure to wash your hands after applying the cream (unless you are using it to treat plaque psoriasis on your hands).

About taking Zoryve

Below you’ll find information about key dosage issues.

• When to use: You should apply Zoryve once daily.Your doctor can tell you the best time of day to apply the cream. It may depend on the area of your body affected by plaque psoriasis.
• Length of use: Zoryve is meant to be used as a long-term treatment. If you and your doctor determine that Zoryve is safe and effective for you, you’ll likely use it long term.

Overdose

Do not use more Zoryve than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Zoryve

If you think you’ve used too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

Common questions about Zoryve

Here are answers to some frequently asked questions about Zoryve.

Can Zoryve be used for atopic dermatitis or eczema?

Possibly. Zoryve may be used off-label for atopic dermatitis (commonly known as eczema). Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

A recent clinical trial showed promising results for adults and children with mild to moderate atopic dermatitis who used roflumilast cream. (Roflumilast is the active drug in Zoryve.) However, the cream used in this trial was a lower strength than Zoryve.

Zoryve comes in one strength of 0.3%. It’s currently FDA approved for use in adults and children ages 12 years and older who have plaque psoriasis.

Talk with your doctor if you have questions about off-label uses of Zoryve.

How does Zoryve work?

It isn’t known exactly how Zoryve works to treat plaque psoriasis.

Plaque psoriasis is a skin condition that involves increased levels of inflammation. Zoryve blocks an enzyme called phosphodiesterase-4 (PDE4). PDE4 plays a role in the body’s inflammatory response. PDE4 also regulates the integrity of epithelial cells. This means PDE4 controls the structure of the cells that line the surface of your tissues and organs, including your skin.

By blocking PDE4, it’s thought that Zoryve may help reduce inflammation, which may reduce or clear the symptoms of plaque psoriasis.

If you have questions about how Zoryve works, talk with your doctor or pharmacist.

Does Zoryve cause long-term side effects?

Zoryve isn’t known to cause long-term side effects.

If you develop any side effects from Zoryve during treatment, they should go away within a few days or weeks after you stop using it. However, you should not stop using Zoryve without first discussing it with your doctor.

If you have questions about using Zoryve long term, talk with your doctor or pharmacist.

Zoryve interactions

Zoryve can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Before taking Zoryve, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications, foods, and supplements

Below is a list of medications, supplements, and foods that can interact with Zoryve. This list does not contain all drugs that may interact with Zoryve. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

* Birth control pills that contain gestodene are not currently available in the United States. However, they are available in other countries.

Alcohol interaction

Alcohol is not known to interact with Zoryve.

If you have questions about how much alcohol is safe to drink while using Zoryve, talk with your doctor or pharmacist.

Things to consider when taking Zoryve

If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.

Zoryve and pregnancy

It’s not known whether Zoryve should be used throughout pregnancy. The drug hasn’t been studied in pregnant people.

However, Zoryve should not be used during labor and delivery. In animal studies, the oral form of roflumilast (the active drug in Zoryve cream) caused problems during labor and delivery.

If you’re planning a pregnancy or can become pregnant, talk with your doctor before using this medication.

Zoryve and birth control

It’s not known if Zoryve is safe to take during pregnancy.

Note that Zoryve may interact with birth control pills that contain gestodene* and ethinyl estradiol. The combination may cause a higher risk or severity of side effects with Zoryve. (For more details, see the “Interactions” section above.)

If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Zoryve. For more information about the type of birth control that’s right for you while using Zoryve, talk with your doctor or pharmacist.

* Birth control pills that contain gestodene are not currently available in the United States. However, they are available in other countries.

Zoryve and breastfeeding

It’s not known whether Zoryve should be used while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before using this medication.

If you and your doctor decide that you’ll use Zoryve while breastfeeding, you should not apply the cream directly to your nipple area to avoid your child ingesting it.