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Overview: Zoryve is a medicine that you apply to your skin for either atopic dermatitis or plaque psoriasis. Do not get Zoryve in your eyesmouthor vagina. Be sure to wash your hands after using unless your hands are being treated. This medicine may cause nauseadiarrheatrouble sleepingor headache. Tell your health care provider if any of these side effects bother you.

Uses

What is Zoryve used for?

Zoryve (roflumilast) is commonly used to treat the following conditions.

  • Plaque psoriasisa skin condition that can cause an itchypainful rash with raised red patches of skin
  • Atopic dermatitisa skin condition that can cause an itchydry rash with scaly patches or blisters

Zoryve foam is commonly used to treat seborrheic dermatitisa skin condition that can cause an itchy rash with flaky skin.

How Zoryve Cream Works for Plaque Psoriasis

Zoryve may also be used for other conditions as determined by your healthcare provider.

Roflumilast is also available as an oral tablet that is taken by mouth. See Roflumilast for more information. 

How does Zoryve work (mechanism of action)?

Zoryve belongs to a group of medicines called phosphodiesterase-4 (PDE4) inhibitors. It is believed to increase the amount of a specific chemical in the body that can help reduce inflammation and pain.

How is Zoryve supplied (dosage forms)?

Zoryve is available in the following dosage forms that are applied to the skin.

  • 0.05% topical cream
  • 0.15% topical cream
  • 0.3% topical cream
  • 0.3% topical foam

How should I store Zoryve?

Topical Cream. Zoryve cream should be stored at room temperaturebetween 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of timesuch as when transporting it. Store in a cooldry place.

Topical Foam. Zoryve foam should be stored at room temperaturebetween 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of timesuch as when transporting it. Store in a cooldry place. Store in an upright position. Do not freeze. Do not puncture the container or expose it to heat (temperature above 120 F or 49 C).

Side Effects

What are the most common side effects of Zoryve?

The most common side effects of Zoryve are listed below. These side effects may vary depending on the condition that is being treated and your age. Tell your health care provider if you have any of these side effects that bother you.

  • Diarrhea
  • Headache
  • Trouble sleeping
  • Nausea or vomiting
  • Pain where the product is applied
  • Infection in the nose or throatsore throator common cold symptoms
  • Kidney or bladder infection
  • Pink eye

There may be other side effects of Zoryve that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S.you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canadayou can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Zoryve?

While less commonthe most serious side effects of Zoryve are described belowalong with what to do if they happen. 

Severe Allergic Reactions. Zoryve may cause allergic reactionswhich can be serious. Stop using Zoryve and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the facelipsmouthtongueor throat
  • Trouble swallowing or throat tightness
  • Itchingskin rashor pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizzinessfeeling lightheadedor fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use Zoryve?

Allergies to Ingredients. People who are allergic to any of the following should not use Zoryve.

  • Roflumilast
  • Zoryve
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Zoryve.

Liver Problems. Zoryve should not be used if your liver is not working as well as it should be. If there is a concern about the health of your liveryour health care provider may do tests to determine if it is working well enough to use this medicine.

What should I know about Zoryve before using it?

Do not use Zoryve unless it has been prescribed to you by a health care provider. Use it as prescribed.

Do not share Zoryve with other peopleeven if they have the same condition as you. It may harm them.

Keep Zoryve out of the reach of children.

Zoryve is for use on the skin only. It should not be used on other areas of the body such as your eyesmouthor vagina. Zoryve foam should be used on dry skin.

Wash your hands after applying Zoryveunless the prescribed treatment area is your hand(s).

If you are using Zoryve foamshake the can well before each use.

Avoid fire or flame (including smoking) shortly after applying Zoryve foam. The contents are flammable.

What should I tell my health care provider before using Zoryve?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicinesvitamins/mineralsherbal productsand other supplements you are using. This will help them determine if Zoryve is right for you.

In particularmake sure that you discuss any of the following.

Liver Problems. Tell your health care provider if you have any known or suspected liver problems. 

Pregnancy. It is not known if or how Zoryve could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Zoryve passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Zoryve while breastfeeding. If you are using Zoryve while breastfeedingdo not apply Zoryve directly to the nipple or areola that comes in direct contact with your baby’s mouth. If Zoryve is applied to your chest areamake sure the treated skin area does not come in direct contact with the baby.

How can I get more information about Zoryve?

For more information about Zoryveyou can visit the drugmaker’s website at www.zoryve.com or call them at 805-418-5006.

Interactions

Does Zoryve interact with foods or drinks?

There are no known interactions between Zoryve and foods or drinks.

It is unknown if drinking alcohol will affect Zoryve.

Does Zoryve interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicinesvitamins/mineralsherbal productsand other supplements you are using. 

In particularmake sure that you discuss if you are using any of the following before using Zoryve.

  • A birth control pill that contains ethinyl estradiol
  • Erythromycin (Ery-Tab and others)which is a medicine used for bacterial infections
  • Ketoconazolewhich is a medicine used for fungal infections
  • Fluvoxaminewhich is a medicine commonly used for anxiety and depression 
  • Cimetidine (Tagamet HB)which is a medicine used for heartburn

Many other medicines may alter the blood levels of roflumilast (the active drug of Zoryve). Tell your health care provider about all medicines that you take or have recently taken. 

This may not be a complete list of medicines that can interact with Zoryve. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Zoryve?

If you or someone else has used too much Zoryveget medical help right awaycall 911or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Zoryve?

If you miss your scheduled application of Zoryveapply it as soon as you remember. If it is almost time for your next scheduled applicationskip the missed application and follow the original schedule. Do not apply Zoryve more often than prescribed.