8 Opzelura Side Effects You Should Know About

Opzelura (ruxolitinib) is a prescription-only cream that’s used to treat certain skin conditions. It belongs to the Janus kinase (JAK) inhibitor medication class. It’s FDA approved for treating mild to moderate atopic dermatitis (eczema) and nonsegmental vitiligo.

While most JAK inhibitors are taken by mouth, Opzelura is a cream that directly treats the skin. This difference means that it may be better tolerated than oral JAK inhibitors. But Opzelura still has some side effects to be aware of.

Opzelura side effects at a glance

As mentioned above, Opzelura tends to have fewer side effects than oral JAK inhibitors. This is because lower amounts of a medication reach the bloodstream when it’s applied to the skin. So less medication is available to affect other areas of the body.

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Common Opzelura side effects (those that happened to 2% or more of people in clinical trials) include:

• Acne where Opzelura is applied

• Itching where Opzelura is applied

• Redness where Opzelura is applied

• Cold symptoms (such as sore throat and runny nose)

• Headaches

• Urinary tract infections

Rare but serious Opzelura side effects include:

• Serious infections caused by bacteria, viruses, or fungi

• Blood clots

• Low blood cell counts

• A higher risk of cancer

• Heart attack

• Stroke

Below, we’ll detail eight Opzelura side effects, plus tips to manage them and when to get help.

1. Acne

People using Opzelura can develop acne where they applied it. This could be due to Opzelura’s effects on the skin. It also may be related to the medication covering the pores, allowing skin oils to build up. Acne was one of the most commonly reported Opzelura side effects in clinical trials.

If your acne is mild, it may go away on its own. But if it’s not going away, or if it’s getting worse, check with your healthcare provider. They may recommend not applying Opzelura on the skin areas where you have acne (if possible). They may also suggest topical or oral acne treatments, depending on how severe it is.

2. Itching or redness

Itching and redness are common side effects of many medications that are applied to the skin. These side effects are also common with Opzelura.

Itching and redness may go away on their own, especially if the symptoms are mild. Applying cold compresses can help relieve these Opzelura side effects. Wearing loose-fitting clothing may help you avoid additional irritation.

If itching or redness isn’t going away or seems to be getting worse, let your healthcare provider know. They can help determine if there’s another cause for your itchy or red skin.

If itching or redness seems to be related to Opzelura, your provider may suggest not applying the medication to that area until it gets better. They may also recommend treating the irritated skin or looking at alternatives to Opzelura.

3. Cold symptoms

Symptoms of the common cold are another potential Opzelura side effect. This can include a stuffy or runny nose, sore throat, and bronchitis (airway inflammation). Headaches, body aches, and fever are also possible symptoms. Just as with the common cold, these symptoms should go away on their own.

If your symptoms are bothersome, there are a few things you can try to get some relief. Drinking plenty of fluids and getting adequate rest can help you feel better. Over-the-counter (OTC) cold medications like decongestants, pain relievers, and nasal sprays can also be helpful.

If your cold symptoms aren’t going away within about a week, let your healthcare provider know. They can help determine next steps.

4. Serious infections

Some people taking oral JAK inhibitors have experienced serious infections. This happens because JAK inhibitors affect the immune system. In fact, all JAK inhibitors have a boxed warning (the FDA’s strictest warning for medications) about serious infections.

With Opzelura, the risk of serious infections is very low. Infections such as pneumonia and sepsis were reported in clinical trials of Opzelura. However, it wasn’t clear if these infections were truly related to the medication.

If you have an active, serious infection, you shouldn’t use Opzelura. And you may need to avoid Opzelura if you have a current long-term infection, a history of serious infections, or health conditions that make infections more likely.

If you have a fever or other symptoms of infection while taking Opzelura, let your healthcare provider know. They can help make sure it’s safe for you to continue applying the medication.

5. Blood clots

In clinical trials of Opzelura, some people using the medication had blood clots. Unwanted blood clots can be harmful, especially if they are in your lungs (pulmonary embolism) or your brain (stroke).

This Opzelura side effect is part of another boxed warning for the medication. Blood clots are rare, but they can be life threatening if they happen. Your healthcare provider may recommend avoiding Opzelura if you have a high risk for blood clots, such as if you’re bedbound following surgery.

If you have symptoms like warmth, redness, and pain in your leg, this could indicate a blood clot. Let your provider right away know if you’re having these symptoms while taking Opzelura.

If you’re having trouble breathing, chest pain, or weakness on one side of your body, it could be due to a blood clot in your lungs or brain. Get immediate medical help by going to the nearest emergency room or calling 911.

6. Changes in blood cell counts

JAK inhibitors like Opzelura can affect how blood cells are made. Because of this, you may have changes in certain blood cell counts. Examples include low platelets, low red blood cells (anemia), and low white blood cells.

These side effects are more common with oral JAK inhibitors than Opzelura. In fact, some experts question whether Opzelura is actually linked to meaningful blood cell count changes. But Opzelura’s manufacturer still warns of this possibility. Your healthcare provider may intermittently monitor your blood cell counts while you’re taking Opzelura to identify any changes.

7. Higher risk of cancer

Oral JAK inhibitors are associated with a higher risk of certain cancers compared to biologic medications like Humira (adalimumab). However, this risk is rare. Opzelura seems to have a more specific risk for skin cancers, since it’s applied to the skin. This medication contains a boxed warning for this serious side effect.

Your healthcare provider should check your skin for signs of skin cancer while you’re using Opzelura. Limiting exposure to sunlight by wearing protective clothing or using sunscreen can help lower your risk for skin cancer.

8. Heart attack or stroke

Opzelura also has a boxed warning for heart attacks and strokes. This warning is because the oral JAK inhibitor Xeljanz (tofacitinib) has been linked to a higher risk of heart attacks or strokes.

Because JAK inhibitors work similarly, the FDA requires all JAK inhibitors that treat autoimmune conditions to have this boxed warning. But these serious side effects haven’t been linked to Opzelura in clinical trials. Still, the medication’s label includes this warning.

Make sure your healthcare provider knows if you have a history of heart problems. Depending on your personal risks, they may recommend an alternative to Opzelura.

When should I contact my healthcare provider about Opzelura side effects?

You can contact your healthcare provider or pharmacist about Opzelura side effects any time you have questions. Even if your symptoms are mild, it’s never a bad idea to double-check if you’re concerned. Keep in mind that mild side effects, such as itchiness, often go away on their own.

But symptoms of serious Opzelura side effects should never be ignored. Seek immediate help if you experience:

• Sudden redness, warmth, or pain in the leg

• Chest pain or shortness of breath

• Numbness or weakness on one side of your body

• Severe headache or dizziness

• Slurred speech or sudden confusion

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Written by:

Austin Ulrich, PharmD, BCACP

Austin Ulrich, PharmD, BCACP, is a board-certified ambulatory care clinical pharmacist. In his early career, he provided direct patient care in a variety of settings, including hospital and community pharmacies, and in a primary care clinic as a clinical pharmacist.

Edited by:

Christina Aungst, PharmD

Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

Reviewed by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

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