Opzelura (ruxolitinib) is a prescription drug used to treat certain skin conditions. Opzelura can cause side effects that range from mild to serious. Examples include infection and certain skin reactions where Opzelura is applied.
Specifically, Opzelura is used in adults and certain children to treat:
The active ingredient in Opzelura is ruxolitinib. (An active ingredient is what makes a drug work.) The drug comes as a topical cream that’s applied to the affected areas of your skin.
Keep reading to learn about the common, mild, and serious side effects that Opzelura can cause. For a general overview of the drug, including details about its uses, see this article.
* “Nonsegmental” means the condition causes discolored patches of skin on both sides of the body.
Below are just a few of the more common side effects reported by people who took Opzelura in studies. These side effects can vary depending on which condition the drug is being used to treat.
More common side effects in people using Opzelura for eczema include:
- hives where Opzelura is applied*
- the common cold
- ear infection
- high level of eosinophils (a type of white blood cell)
More common side effects in people using Opzelura for nonsegmental vitiligo include:
* To learn more about this side effect, see “Skin reactions” in the “Side effects explained” section below.
Mild side effects have been reported with Opzelura. These side effects can vary depending on which condition the drug is being used to treat.
Mild side effects that have been reported in people using Opzelura for eczema include:
- mild infection, such as the common cold, bronchitis, and ear infection
- high level of eosinophils
- runny nose
- swollen tonsils
- skin reactions where Opzelura is applied*
- mild allergic reaction*†
Mild side effects that have been reported in people using Opzelura for nonsegmental vitiligo include:
- mild infection, such as the common cold and urinary tract infection (UTI)
- skin reactions where Opzelura is applied*
- mild allergic reaction*†
In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. And do not stop using Opzelura unless your doctor recommends it.
Opzelura may cause mild side effects other than those listed above. See the drug’s prescribing information for details.
* To learn more about this side effect, see the “Side effects explained” section below.
† An allergic reaction is possible after using Opzelura, but this side effect wasn’t reported in studies.
Serious side effects have been reported with Opzelura. These include:
- low levels of red blood cells, platelets, and neutrophils
- boxed warnings: serious infections, cancer, heart and blood vessel problems, blood clots, and increased risk of death*
- severe allergic reaction*†
If you develop serious side effects while using Opzelura, 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.
Note: After the FDA approves a drug, it tracks and reviews side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Opzelura, visit MedWatch.
Get answers to some frequently asked questions about Opzelura’s side effects.
How do side effects of Opzelura compare with those seen with Eucrisa?
Both Opzelura and crisaborole (Eucrisa) may cause skin reactions where the drug is applied. But Opzelura may cause other side effects that Eucrisa isn’t known to cause.
For example, Opzelura may cause diarrhea, runny nose, and headache. Opzelura also has several boxed warnings* for serious risks, including cancer and blood clots. These side effects and risks aren’t known to occur with Eucrisa.
To learn more about Eucrisa’s side effects, see this article. Your doctor or pharmacist can also provide more information.
* Boxed warnings are the most serious warnings from the FDA. To learn more about these risks, see the “Side effects explained” section below.
Does Opzelura cause long-term side effects?
Long-term side effects from Opzelura are rare but possible. Opzelura may cause side effects that lead to long-term problems, even after you stop using the drug.
Examples of long-term side effects reported in Opzelura’s studies include serious infections, cancer, and blood clots. In fact, Opzelura has boxed warnings for these risks and others. To learn more, see the “Side effects explained” section below.
To learn more about possible side effects of Opzelura and how long they may last, talk with your doctor or pharmacist.
Learn more about some of the side effects Opzelura may cause.
Opzelura has boxed warnings for the following risks. (A boxed warning is the most serious warning from the FDA.)
Opzelura may cause serious infection in some people. This was a rare side effect reported in studies of the drug. Examples of these infections include chest infections such as pneumonia. In severe cases, these infections may require treatment in a hospital and can even be life threatening.
Symptoms can vary depending on the specific infection. But examples of symptoms to watch for include fever, cough, shortness of breath, and body aches.
Several factors can increase the risk of serious infection when using this drug. These include:
- having a condition, such as HIV, that weakens the immune system
- having a current or past infection that’s long lasting or keeps coming back
- traveling to places with a higher risk of certain fungal infections
- being exposed to tuberculosis (TB)
What might help
Before prescribing Opzelura, your doctor may test you for TB and certain other infections. If these tests show that you have an infection, your doctor will likely treat it before you start Opzelura treatment.
If you have symptoms of an infection during your Opzelura treatment, talk with your doctor. They can test you for infection and prescribe treatment if needed. They may also have you temporarily stop using Opzelura until your infection clears. Your doctor will tell you when it’s safe to continue using the drug.
Symptoms of skin cancer may include skin growths or patches that are discolored or irregularly shaped.
What might help
If you have symptoms of cancer during Opzelura treatment, talk with your doctor. They can order tests to check for cancer. If the tests show that you have cancer, your doctor can determine whether it’s safe for you to continue using Opzelura.
During your Opzelura treatment, your doctor may recommend that you have frequent skin cancer screenings. They can also recommend other ways to reduce your risk of skin cancer. These include wearing sunscreen and long sleeves, pants, and hats that protect against ultraviolet (UV) radiation.
Heart and blood vessel problems
Heart and blood vessel problems were not reported in studies of Opzelura. But these side effects have occurred with oral Janus kinase (JAK) inhibitors. Opzelura is a JAK inhibitor, but it’s a topical cream applied to the skin rather than an oral drug.
Heart and blood vessel problems include heart attack, stroke, and death related to a heart problem. Symptoms of a heart attack can include pain or discomfort in your jaw, neck, chest, or arms. Symptoms of a stroke can include difficulty speaking and weakness in one side of your body.
Certain factors may increase the risk of heart and blood vessel problems when using this drug. These include:
- whether you currently smoke or have smoked before
- having a condition that increases the risk of heart disease, such as high blood pressure
It isn’t known for certain whether Opzelura increases the risk of heart and blood vessel problems. To learn more about this warning, talk with your doctor.
What might help
If you have symptoms of a heart attack or stroke during Opzelura treatment, call 911 or a local emergency number right away.
If you experience heart or blood vessel problems with Opzelura, your doctor will likely have you stop using the drug. They can suggest other treatment options for your condition.
Blood clots may cause symptoms such as:
- swelling, pain, or discoloration around the affected area
- chest pain
- shortness of breath
What might help
If you have symptoms of a blood clot during Opzelura treatment, call 911 or seek emergency medical care right away.
If you have a blood clot while using Opzelura, your doctor may stop the drug and suggest alternative treatments instead.
Increased risk of death
An increased risk of death was not reported in studies of Opzelura. However, oral Janus kinase (JAK) inhibitors may increase this risk in certain people. Opzelura is a JAK inhibitor, but it’s a topical cream applied to the skin rather than an oral drug.
The risk with oral JAK inhibitors affects adults ages 50 years and older with at least one condition that increases their risk of heart disease. Examples include high cholesterol and high blood pressure.
It’s not known for certain whether Opzelura increases the risk of death for people in this group.
What might help
Your doctor will review your health history and determine whether Opzelura may be a safe treatment option for you. To learn more about this risk, talk with your doctor.
Opzelura can cause a variety of skin reactions where the drug is applied. Certain reactions were more common than others in studies of Opzelura. These reactions may vary depending on which condition the drug is being used to treat.
For example, hives and swollen hair follicles were common in people using Opzelura for eczema in studies. Acne, itchiness, and discoloration or redness were common in people using Opzelura for nonsegmental vitiligo. Rare skin reactions that occurred with this use include swollen or discolored skin and swollen hair follicles.
What might help
If you have a skin reaction during your Opzelura treatment, talk with your doctor or pharmacist. They can recommend options for managing this side effect. For example, if you have swollen hair follicles, they may recommend not shaving, waxing, or plucking hairs in the affected areas.
Symptoms can be mild to serious and can include:
- skin rash
- flushing (temporary warmth, redness, or deepening of skin color)
- swelling under your skin (usually in your eyelids, lips, hands, or feet)
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What might help
If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:
- an oral antihistamine, such as diphenhydramine (Benadryl)
- a product you apply to your skin, such as hydrocortisone cream
If your doctor confirms you’ve had a mild allergic reaction to Opzelura, they’ll decide whether you should continue using it.
If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.
If your doctor confirms you’ve had a serious allergic reaction to Opzelura, they may have you switch to a different treatment.
Keeping track of side effects
During your Opzelura treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start taking a new drug or using a combination of treatments.
Your side effect notes can include things such as:
- how much of the drug you applied to your skin
- how soon you had the side effect after starting that dose
- what your symptoms were
- how your symptoms affected your daily activities
- what other medications you were taking
- any other information you feel is important
Keeping notes and sharing them with your doctor will help them learn more about how Opzelura affects you. They can then use this information to adjust your treatment plan if needed.
Below is important information you should consider before using Opzelura.
Opzelura has boxed warnings about the following risks. Boxed warnings are the most serious warnings from the FDA.
Risk of serious infections: Using Opzelura may lead to serious infection. Although rare, these infections may require treatment in a hospital and can even be life threatening.
Risk of heart and blood vessel problems: Using Opzelura may lead to rare cases of heart attack, stroke, or death related to a heart problem.
Risk of blood clots: In rare cases, using Opzelura may lead to blood clots. These can be life threatening in severe cases.
Increased risk of death: Using Opzelura may increase the risk of death in adults ages 50 years and older with at least one condition that increases their risk of heart disease.
To learn more about these warnings, see the “Side effects explained” section above.
Opzelura can sometimes cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Opzelura is a good treatment option for you.
Talk with your doctor about your health history before you use Opzelura. Be sure to tell them if any of the following factors apply to you:
- previous allergic reaction to Opzelura
Alcohol and Opzelura
There are no known interactions between alcohol and Opzelura. But drinking alcohol may trigger symptoms of eczema in some people. (Opzelura is used to treat eczema.) If you drink alcohol and it’s an eczema trigger for you, your doctor may advise you to avoid or limit alcohol during your Opzelura treatment.
If you have questions about consuming alcohol with Opzelura, talk with your doctor or pharmacist.
Pregnancy and breastfeeding with Opzelura
Before starting Opzelura treatment, it’s important to talk with your doctor if you’re pregnant, breastfeeding, or planning to become pregnant or to breastfeed.
It’s not known whether it’s safe to use Opzelura during pregnancy. If you’re pregnant or planning to become pregnant, talk with your doctor before starting Opzelura treatment.
If you use this drug while pregnant, consider signing up for the drug’s pregnancy registry. A pregnancy registry collects information about the safety of certain drugs when used during pregnancy. You can sign up or learn more about Opzelura’s pregnancy registry by calling 855-463-3463.
Opzelura may not be safe to use while breastfeeding. The drug manufacturer recommends that you do not breastfeed during Opzelura treatment and that you wait at least 4 weeks after your last dose before breastfeeding.
If you’re breastfeeding or planning to do so, talk with your doctor about your options.
Like most drugs, Opzelura can cause side effects that range from mild to serious. However, most are temporary and go away after a few days to weeks. If you have questions about side effects that Opzelura can cause, talk with your doctor.
Examples of questions you may want to ask include:
- Do any of the other medications I take increase my risk of side effects with Opzelura?
- If I have side effects while using Opzelura, should I apply the drug less often?
- Are there ways to reduce my risk of side effects from Opzelura?
To learn more about Opzelura, see this article.
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Disclaimer: Healthline 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.