Opzelura (ruxolitinib) is a brand-name skin cream that’s prescribed for atopic dermatitis, also called eczema, and vitiligo in adults and certain children. Like other drugs, Opzelura can cause side effects, such as infections and skin reactions.
Opzelura has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section below.
Opzelura 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 Opzelura in clinical trials:
- common cold
- headache
- itchy skin, warmth, deepening of skin color, or discoloration at the application site
- acne at the application site
Mild side effects can occur with Opzelura use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Opzelura’s prescribing information.
Mild side effects that have been reported with Opzelura include:
- itchy skin, warmth, deepening of skin color, or discoloration at the application site
- acne or hives at the application site
- mild infections, such as the common cold, urinary tract infection, tonsillitis, bronchitis, and ear infection
- folliculitis (swollen hair follicles)
- diarrhea
- headache
- fever
- runny nose
- increased levels of white blood cells called eosinophils
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 FDA approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while using Opzelura and want to tell the FDA about it, visit MedWatch.
Opzelura may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Opzelura’s prescribing information.
If you develop serious side effects while taking 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.
Serious side effects that have been reported and their symptoms include:
- low levels of white blood cells, which may cause symptoms such as:
- fever
- infection
- low levels of red blood cells, which may cause symptoms such as:
- low levels of platelets (blood cells that help with blood clotting), which may cause symptoms such as:
- bruising
- bleeding
- risk of certain types of cancer*
- risk of serious infection*
- risk of heart and blood vessel problems*
- risk of blood clots*
Opzelura may also increase the risk of death in certain people.*
* For more information about these side effects, see “Side effect specifics” below.
ALLERGIC REACTIONFor some people, Opzelura cream can cause an allergic reaction. But this side effect wasn’t reported in the drug’s studies.
In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep using the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Opzelura cream, your doctor may recommend using a different medication instead.
Opzelura may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
Are there reviews of Opzelura cream side effects?
It’s possible to find reviews of Opzelura cream side effects online. However, keep in mind that different people will likely have different experiences with Opzelura. This will depend on their personal circumstances. Reviews of Opzelura side effects on websites may not apply to your personal situation.
How well Opzelura works for you and whether you have side effects with the cream will depend on your health history, as well as other individual factors. To learn more about what you can expect with Opzelura, talk with your doctor.
Do steroids cause the same side effects as Opzelura?
Opzelura and steroids, also called corticosteroids, can cause some similar and some different side effects. For example, both can cause application site reactions such as itchy skin or discoloration. Corticosteroids can also cause skin thinning and stretch marks, but Opzelura doesn’t cause these side effects.
Opzelura can cause mild infections, such as the common cold. It also has several boxed warnings for serious risks, including cancer and blood clots. These side effects and risks aren’t known to occur with corticosteroids. For more information about these side effects, see “Side effect specifics” below.
Corticosteroids are medications that reduce inflammation (swelling and pain). Similar to Opzelura, corticosteroids can be used to treat eczema and vitiligo. But Opzelura is not a corticosteroid. Instead, it’s a type of medication called a Janus kinase (JAK) inhibitor.
To learn more about how Opzelura compares with corticosteroids, talk with your doctor or pharmacist.
Learn more about some of the side effects that Opzelura may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Opzelura.
Cancer
Opzelura has a boxed warning for the risk of certain types of cancer. A boxed warning is the most serious warning from the FDA. Nonmelanoma skin cancers, such as squamous cell carcinoma and basal cell carcinoma, were reported rarely in clinical trials of Opzelura.
Other types of cancer, such as lymphoma and lung cancer, have been reported with oral JAK inhibitor medications. Opzelura is a topical JAK inhibitor that’s applied to the skin. But the medication can still get absorbed by your body through your skin. So it can still raise your risk of these cancers and others.
Cancer symptoms can vary depending on the type of cancer. Symptoms of nonmelanoma skin cancer can include skin patches or growths that have an irregular shape or different color from nearby skin.
If you smoke or used to smoke, you may have a higher risk of developing cancer while using Opzelura.
What you can do
Before you start using Opzelura, tell your doctor if you’ve ever had cancer or used to smoke. This can help your doctor determine if Opzelura is safe for you.
To help prevent skin cancers while using Opzelura, you should try to avoid exposing your skin to excessive sunlight. Use sunscreen and wear clothing and a hat to protect your skin from the sun’s harmful rays.
Your doctor may examine your skin from time to time to check for signs of skin cancer while you’re using Opzelura.
If you have questions about the risk of developing cancer when using Opzelura, talk with your doctor.
Serious infections
Opzelura has a boxed warning about the risk of serious infections. A boxed warning is the most serious warning from the FDA. These infections may need treatment in the hospital and can even be life threatening. In clinical trials of Opzelura, serious infections were reported rarely. Examples include shingles and serious lower respiratory tract infections, such as pneumonia.
Other serious infections have been reported with oral JAK inhibitor medications. Opzelura is a JAK inhibitor that’s applied to the skin. But your body can still absorb the medication through your skin. So it may also raise your risk of other serious infections.
Symptoms of serious infections can vary depending on the type of infection. They can include fever, chills, cough, shortness of breath, body aches, and burning skin rash.
If you have a weak immune system, you may have a higher risk of serious infections while using Opzelura. You may also have an increased risk if you live in or travel to areas with a high risk of certain infections, such as tuberculosis.
What you can do
Before you start using Opzelura, tell your doctor if you have any active or ongoing infections or infections that keep coming back. Also tell your doctor about infections you have had in the past, especially tuberculosis, hepatitis B, hepatitis C, and chickenpox. And talk with your doctor about your vaccination history.
If you have an active infection, your doctor may prescribe a medication to treat it before you start using Opzelura. If needed, your doctor may also recommend getting certain vaccinations to help prevent infections before you start treatment.
While using Opzelura, see your doctor right away if you have symptoms of an infection. Your doctor may prescribe medication to treat the infection. If the infection is serious, they may also have you stop using Opzelura until the infection is managed.
If you have questions about the risk of infections with Opzelura, talk with your doctor.
Heart and blood vessel problems
Opzelura has a boxed warning about the risk of heart and blood vessel problems. A boxed warning is the most serious warning from the FDA.
In clinical trials of Opzelura, no heart and blood vessel problems were reported. However, serious heart and blood vessel problems, such as heart attack and stroke, have been reported with oral JAK inhibitor medications. Opzelura is a JAK inhibitor that’s applied to the skin. But your body can still absorb the medication through your skin. So it may raise your risk of these problems.
Symptoms of heart attack can include pain, pressure, or tightness in your chest, neck, jaw, or arm. Symptoms of stroke can include weakness in one side of your face or body and trouble speaking.
If you smoke or used to smoke, you may have a higher risk of heart and blood vessel problems while using Opzelura. Heart disease or heart disease risk factors, such as high blood pressure, obesity, or diabetes, may also increase the risk of these problems.
What you can do
While using Opzelura, call 911 or your local emergency number right away if you have symptoms of heart attack or stroke.
Before you start using Opzelura, talk with your doctor about any risk factors you may have for heart and blood vessel problems. This can help your doctor determine if Opzelura is safe for you.
If you have questions about the risk of heart and blood vessel problems when using Opzelura, talk with your doctor.
Blood clots
Opzelura has a boxed warning about the risk of blood clots. A boxed warning is the most serious warning from the FDA. In clinical trials of Opzelura, blood clots were reported rarely.
Blood clots have also been reported with oral JAK inhibitor medications. Examples include deep vein thrombosis (clot in the leg or arm) and pulmonary embolism (clot in the lungs). Opzelura is a JAK inhibitor that’s applied to the skin. But your body can still absorb the medication through your skin.
Symptoms of deep vein thrombosis can include pain, swelling, warmth, or skin discoloration in your leg or arm. Symptoms of pulmonary embolism can include chest pain and shortness of breath.
If you have heart disease or heart disease risk factors, such as high blood pressure, smoking, obesity, or diabetes, you may have a higher risk of blood clots when using Opzelura.
What you can do
While using Opzelura, see your doctor right away if you have symptoms of deep vein thrombosis. But if you have symptoms of a pulmonary embolism, call 911 or your local emergency number right away.
Before you start using Opzelura, talk with your doctor about any risk factors you may have for blood clots. This can help your doctor determine if Opzelura is safe for you.
If you have questions about the risk of blood clots when using Opzelura, talk with your doctor.
Increased risk of death
Opzelura has a boxed warning about the increased risk of death. A boxed warning is the most serious warning from the FDA.
In clinical trials of Opzelura, no increased risk of death was reported. However, an increased risk of death has been reported in certain people taking oral JAK inhibitor medications. These people were ages 50 years and older and had heart disease risk factors, such as high blood pressure, history of smoking, or diabetes.
Opzelura is a JAK inhibitor that’s applied to the skin. But your body can still absorb the medication through your skin. It’s not known if Opzelura can increase the risk of death.
What you can do
Before you start using Opzelura, talk with your doctor about any heart disease risk factors you may have. This can help your doctor determine if Opzelura is safe for you.
If you have questions about the possible increased risk of death when using Opzelura, talk with your doctor.
Below is important information you should consider before using Opzelura.
Opzelura has boxed warnings. A boxed warning is the most serious warning from the FDA. For details, see the “Side effect specifics” section above.
Other precautions
Before taking Opzelura, discuss your health history with your doctor. Opzelura may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
- previous allergic reaction to this or a similar drug
- pregnancy
- breastfeeding
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.