Zoryve (roflumilast) is a brand-name topical cream that’s prescribed for plaque psoriasis in adults and certain children. As with other drugs, Zoryve can cause side effects, such as diarrhea and headache.

Zoryve can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who used Zoryve in clinical trials:

* For more information about this side effect, see “Side effect specifics” below.

Mild side effects can occur with Zoryve use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Zoryve’s prescribing information.

Mild side effects that have been reported with Zoryve include:

These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while using Zoryve and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after using Zoryve. However, this side effect wasn’t reported in clinical trials. To learn more, see the “Side effect specifics” section below.

Serious side effects weren’t reported with the use of Zoryve.

As with many drugs, it’s possible for Zoryve to cause a severe allergic reaction. However, this wasn’t reported in the drug’s clinical trials. To learn more, see the “Side effect specifics” section just below.

If you develop serious side effects while using Zoryve, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Learn more about some of the side effects that Zoryve may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Zoryve.

Insomnia

Zoryve may cause insomnia during treatment. However, this side effect wasn’t common in the drug’s clinical trials.

With insomnia, you may have difficulty falling asleep or staying asleep. For example, you may frequently wake up in the middle of the night and be unable to fall back asleep. Insomnia can cause excessive sleepiness.

This side effect may go away over time as your body adjusts to Zoryve. However, persistent lack of sleep may contribute to other problems, including:

What you can do

If you have trouble sleeping after you start using Zoryve, talk with your doctor or pharmacist. They can recommend ways to improve your sleep. For example, they may suggest taking an over-the-counter (OTC) sleep aid such as melatonin or magnesium.

However, if your insomnia is persistent, bothersome, or severe, your doctor may recommend a different treatment option for your plaque psoriasis.

Diarrhea

It’s possible to develop diarrhea while using Zoryve. However, this was not a commonly reported side effect in the drug’s clinical trials. If you do develop diarrhea, it may go away over time as your body adjusts to Zoryve.

With diarrhea, you have unusually loose or watery stools. Although these were not reported in clinical trials, it’s possible for diarrhea to occur with the following symptoms:

Persistent diarrhea may lead to dehydration.

What you can do

If you experience diarrhea from using Zoryve, it will likely resolve on its own. However, due to the risk of dehydration, it’s important to stay hydrated with water or electrolyte drinks.

Eating bland foods, such as rice and oatmeal, may help thicken your stool. In contrast, you should avoid foods and drinks that are high in sugar. Sugar-free gum and other foods containing artificial sweeteners may also worsen diarrhea. For more information about foods to eat and avoid with diarrhea, see this article.

If you have persistent or worsening diarrhea, talk with your doctor or pharmacist. They may recommend a prescription or OTC antidiarrheal medication to help treat this side effect.

Allergic reaction

As with most drugs, Zoryve can cause an allergic reaction in some people. However, this side effect wasn’t reported in clinical trials.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep using Zoryve. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Be sure to talk with your doctor about your health history before you use Zoryve. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These include:

Liver problems: If you have a liver problem, such as liver disease, talk with your doctor before they prescribe Zoryve. Your liver plays an important role in removing drugs from your body. If your liver doesn’t function as well as expected, Zoryve can build up in your system. This may increase your risk of side effects during treatment. If you have a liver problem, your doctor may not prescribe Zoryve. However, they can recommend a different treatment option for your psoriasis.

Allergic reaction: If you’ve had an allergic reaction to Zoryve or any of its ingredients, your doctor will likely not prescribe Zoryve. Ask your doctor what other medications may be better options for you.

Pregnancy or breastfeeding: It’s not known whether Zoryve is safe to use during pregnancy or while breastfeeding. If you’re pregnant, breastfeeding, or planning for either, talk with your doctor before they prescribe Zoryve. They’ll determine whether Zoryve is safe for you and your child.

Alcohol consumption: There are no known interactions between Zoryve and alcohol. Your doctor can advise on how much alcohol, if any, is safe to drink during treatment with Zoryve.

Side effects aren’t common with the use of Zoryve. If side effects do occur, they are usually mild and tend to go away on their own after a few days to weeks. You should talk with your doctor if you have any side effects that last, are bothersome, or are serious.

If you’d like to learn more about Zoryve, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from using the drug.

Besides talking with your doctor, you can do some research on your own. These articles might help:

  • More information about Zoryve: For details about other aspects of Zoryve, refer to this article.
  • Cost: If you’d like to learn about Zoryve and cost, see this article.
  • Dosage: For information about the dosage of Zoryve, view this article.
  • A look at your condition: For details about plaque psoriasis, see our psoriasis hub.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.