8 Opzelura Side Effects You Should Know About
Opzelura is a cream for atopic dermatitis and nonsegmental vitiligo. Common Opzelura side effects include acne and itchy skin.
Opzelura
Used for Eczema, Vitiligo
Used for Eczema, Vitiligo
Opzelura (ruxolitinib) is a topical Janus kinase (JAK) inhibitor. It's a non-steroid cream used to treat atopic dermatitis (eczema) in people 2 years and older. It can also treat nonsegmental vitiligo (a condition that causes patches of skin to lose color) in people 12 years and up. Opzelura (ruxolitinib) is applied onto the affected skin twice a day. Common side effects of Opzelura (ruxolitinib) include acne, itching, redness, and cold symptoms.
What is Opzelura (ruxolitinib)?
What is Opzelura (ruxolitinib) used for?
How Opzelura (ruxolitinib) works
Opzelura (ruxolitinib) is a Janus kinase (JAK) inhibitor. It works by blocking proteins called Janus kinases (JAK). These proteins play a role in causing inflammation and other autoimmune problems.
By blocking JAK1 and JAK2, Opzelura (ruxolitinib) helps calm down your immune system. For eczema, this helps reduce skin inflammation, such as redness, swelling, and itching. For nonsegmental vitiligo, it helps stop your immune system from attacking the skin cells that give your skin its color.
When does Opzelura (ruxolitinib) start working?Time passed since treatment started:
Drug facts
| Common Brands | Opzelura |
|---|---|
| Drug Class | JAK inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
More on Opzelura (ruxolitinib) essentials
Side effects of Opzelura (ruxolitinib)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Atopic dermatitis (eczema)
Ages 12 years and older:
- Cold symptoms (e.g., runny nose, sore throat; 3%)
- Bronchitis (1%)
- Ear infection (1%)
- Hives (1%)
- Diarrhea (1%)
- Redness and swelling around hair pores (1%)
- Tonsillitis (1%)
Ages 2 to under 12 years:
- Upper respiratory tract infection (15%)
- COVID-19 (5%)
- Application site reaction (e.g., pain, irritation, itching; 5%)
- Fever (2%)
- Low white blood cell count (2%)
Nonsegmental vitiligo
Ages 12 years and older:
- Acne at the application site (6%)
- Itching at the application site (5%)
- Cold symptoms (e.g., runny nose, sore throat; 4%)
- Headache (4%)
- Urinary tract infection (2%)
- Redness at the application site (2%)
- Fever (1%)
Opzelura (ruxolitinib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infection: fever, chills, sweating, weakness, trouble breathing, cough that doesn't go away, severe stomach pain, burning when you urinate, urinating more often
- Deep vein thrombosis (blood clot in the leg): leg cramp, leg swelling, leg pain, muscle tightness
- Pulmonary embolism (blood clot in the lung): cough, trouble breathing, chest pain, racing heart
- Blood clot near the heart (e.g., heart attack): chest pain or tightness; pain in the jaw, neck, or back; shortness of breath; cold sweat; feeling weak or lightheaded; nausea
- Stroke: sudden weakness on one side of the body, a drooping face, trouble speaking, trouble walking, confusion, dizziness
- Serious bleeds: bleeding or bruising easily, bleeding that's hard to stop, coughing up blood, stomach pain, blood in urine or stool
When do Opzelura (ruxolitinib) possible side effects begin and end?
Time passed since treatment started:
H
D
W
M
Itching at application site
Risk of infections
If a line continues to the right, you'll likely keep experiencing this side effect once it starts.
More on Opzelura (ruxolitinib) side effects
The following Opzelura (ruxolitinib) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Acne
- Diarrhea
- Headache
- Runny or stuffy nose
- Sore throat
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Pros and cons of Opzelura (ruxolitinib)
Pros
- A non-steroid treatment option
- Applied directly onto the affected skin
- Approved for use in adults and some children (depending on the skin condition)
- Might be helpful when other treatments haven't worked well
Cons
- Applied twice a day
- Can't be used on large areas of the skin
- Can take a few months of regular use to see results
- Potential for serious side effects, like infections, even though it's applied to the skin
Pharmacist tips for Opzelura (ruxolitinib)
- Opzelura (ruxolitinib) is for use on the skin only. Apply it twice a day only to areas affected by eczema or vitiligo. This can include sensitive areas like the face, eyelids, and skin folds. But don't get the medication in your eyes, mouth, or vagina. This can cause irritation and other side effects.
- After applying Opzelura (ruxolitinib), wash your hands well with soap and water, unless your hands are being treated. This helps prevent the medication from getting onto other parts of your body. For example, it can avoid getting the medication into your eyes by mistake.
- Don't cover the treated area with tight bandages or wraps. This can cause too much Opzelura (ruxolitinib) to get absorbed into your body. It might raise your risk of side effects.
- You can use other skin care products on areas treated with Opzelura (ruxolitinib). This includes sunscreen, makeup, and moisturizers. Just be sure to wait at least 10 minutes after applying Opzelura (ruxolitinib) before putting other products on the same area. This is how long it takes the medication to dry on the skin.
- Follow your prescriber's instructions for how much Opzelura (ruxolitinib) to use during a given amount of time. Don't use more than one 60-gram tube in 1 week or one 100-gram tube in 2 weeks. If you feel like you need more than this, talk with your prescriber. They can help decide if Opzelura (ruxolitinib) is still the right treatment for you or if another option might work better.
- For eczema: Keep using Opzelura (ruxolitinib) until your eczema symptoms get better. But if your skin doesn't improve within 2 months, talk to your prescriber. They'll examine your skin again and discuss what the next steps are.
- For vitiligo: Keep using Opzelura (ruxolitinib) twice a day as prescribed, even if you don't see results right away. It can sometimes take 6 months or longer to see results that you're happy with. If you're not satisfied after 6 months, talk to your prescriber to get your skin re-evaluated.
- Tell your prescriber about all the medications you take. Even though Opzelura (ruxolitinib) is a skin cream, it can still interact with some medications. Certain antifungals or antibiotics can raise your risk of side effects from Opzelura (ruxolitinib). Also, medications that can weaken your immune system might raise your risk of serious infections even more. Your prescriber can make sure your medications are safe to use together.
- How to store Opzelura (ruxolitinib): Store the medication at room temperature (68ºF to 77ºF). Don't put it in the refrigerator or freezer because this could damage the medication.
- If you're pregnant or thinking of getting pregnant: Talk to your prescriber or obstetrician-gynecologist (OB-GYN) about the risks and benefits. There isn't enough research to know how safe Opzelura (ruxolitinib) is during pregnancy. If you use it while pregnant, you're encouraged to join the Opzelura pregnancy registry. This program helps researchers learn more about the medication's safety during pregnancy. To enroll, call 1-855-463-3463 or visit the website.
- If you're thinking about breastfeeding: Avoid nursing your baby while using Opzelura (ruxolitinib) and for at least 1 month after you stop using it. This medication can absorb into the skin and possibly pass into breast milk. There's a potential for serious side effects in your breastfed baby. Talk with your care team or a lactation consultant about safer ways to feed your baby.
Risks and warnings for Opzelura (ruxolitinib)
Opzelura (ruxolitinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk of serious infections
- Risk factors: History of or current serious infection | Past infections that keep coming back | Other conditions that raise your risk of infection | Living in or traveling to places with high rates of TB infections | Taking medications that weaken your immune system
People who took oral JAK inhibitors have had serious infections caused by bacteria, fungi, or viruses. Sometimes, these infections can be life-threatening.
It's not clear if Opzelura (ruxolitinib) carries the exact same risk. But some people using Opzelura (ruxolitinib) have had serious lung infections or shingles.
Before starting Opzelura (ruxolitinib), tell your prescriber about your medical history. This includes serious infections you currently have or have had. Opzelura (ruxolitinib) isn't recommended if you have an active infection. It also isn't recommended for people with hepatitis B or hepatitis C. Your prescriber can help make sure the medication is safe for you.
While using Opzelura (ruxolitinib), watch for signs of infection. This includes a fever, chills, body aches, cough, or night sweats. If you notice these symptoms, contact your care team so they can give you the care you need.
Possible higher risk of death, heart attack, or stroke
- Risk factors: Age 50 years and older | High blood pressure | High cholesterol | High blood sugar | People who smoke or have smoked
In a study, older adults with rheumatoid arthritis and at least one heart-related risk factor who took oral JAK inhibitors had a higher risk of death. The study also showed that there was a higher risk of heart attack or stroke as well. This was compared to treatment with medications called TNF blockers.
It's not known if Opzelura (ruxolitinib), which is used topically on the skin, has the same risk. Talk to your prescriber about the risks and benefits of using Opzelura (ruxolitinib).
Call 911 right away if you notice signs of a heart attack. This can include chest pain, pressure, tightness, or heaviness. Other signs are pain in your throat, neck, or jaw; shortness of breath; a cold sweat; or nausea.
Also get medical help as soon as you can for signs of a stroke. This includes weakness on one side of your body, a drooping face, slurred speech, or trouble walking.
Possible risk of cancer
- Risk factors: History of cancer | People who smoke or have smoked
Some people who took oral JAK inhibitors have developed cancer during treatment. These cancers included lymphoma and non-melanoma skin cancer.
It's not known if Opzelura (ruxolitinib) has the same risk of cancer. But there have been reports of non-melanoma skin cancer with the medication. To be safe, tell your prescriber about your full medical history, especially if you've had cancer or have smoked. They can talk with you about this risk.
To lower your risk of skin cancer while using Opzelura (ruxolitinib), get regular skin checks as recommended by your prescriber. Wear protective clothing and use sunscreen if you're out in the sun. Also, avoid tanning beds and other sources of ultraviolet (UV) light. Let your prescriber know if you notice any new or unusual changes to your skin.
Possible risk of blood clots
Blood clots have happened in clinical studies with Opzelura (ruxolitinib). Blood clots can form in different parts of the body and block blood flow. This can sometimes be serious and life-threatening.
Tell your prescriber about your medical history so they can check your risk of blood clots. If you're at higher risk, you should avoid using Opzelura (ruxolitinib).
Be aware of the signs and symptoms of a blood clot.
- Deep vein thrombosis (DVT, blood clot in the leg): leg cramp, leg swelling, leg pain, muscle tightness
- Pulmonary embolism (PE, blood clot in the lungs): cough, chest pain, trouble breathing, racing heart
- Blood clot near the heart (heart attack): chest pain; pain in the jaw, neck, or back; shortness of breath; feeling weak or lightheaded; cold sweat; nausea
- Blood clot in the brain (stroke): sudden weakness on one side of your body, droopy face, trouble speaking, trouble walking, confusion
If any of these symptoms happen, get medical help right away. You'll likely need to stop using Opzelura (ruxolitinib).
Low blood cell counts
- Risk factors: History of low blood cell counts
In studies, some people developed low blood cell counts while using Opzelura (ruxolitinib). This includes low red blood cells, which can put you at risk of feeling very tired and anemia. It can also include low platelets, which can make bleeding or bruising easier. And, it could mean low white blood cells, which can make it more likely for you to get sick.
Watch for possible symptoms of low blood cell counts, such as:
- Anemia: tiredness, headache, pale skin, fast heart rate, shortness of breath
- Bleeding (low platelet count): small, flat red spots under your skin, blood in your urine or stool, easy bleeding or bruising
- Infections: fever, chills, tiredness, body aches, lasting cough, runny nose
If you have any of these symptoms, let your care team know. Your prescriber will likely order blood draws to check your blood cell counts. If they're very low, you might need to stop using Opzelura (ruxolitinib).
Higher cholesterol
The tablet form of ruxolitinib, called Jakafi, can raise cholesterol. It's not known if Opzelura (ruxolitinib) has the same effect.
Tell your prescriber if you already have high cholesterol or take cholesterol medications. They can decide if you need to check your cholesterol levels more often while you're using Opzelura (ruxolitinib).
Opzelura (ruxolitinib) dosage
The average cost for 1 tube of 60g of 1.5% of Opzelura (ruxolitinib) is $0.00 with a free GoodRx coupon. This is 100.00% off the average retail price of $2,421.42. 
Tube of cream
Tube of cream| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 60g of 1.5% | 1 tube | $0.00 | $0.00 |
| 100g of 1.5% | 1 tube | $0.00 | $0.00 |
Typical dosage for Opzelura (ruxolitinib)
-
Eczema: Apply a thin layer of cream to the affected area(s) twice a day. Don't apply to more than 20% of your body surface area.
- People ages 12 years and older: Don't use more than one 60-gram tube of Opzelura (ruxolitinib) every week, or one 100-gram tube every 2 weeks.
- Children ages 2 to under 12 years: Don't use more than one 60-gram tube of Opzelura (ruxolitinib) every 2 weeks.
-
Vitiligo: Apply a thin layer of cream to the affected area(s) twice a day. Don't apply to more than 10% of your body surface area. Don't use more than one 60-gram tube of Opzelura (ruxolitinib) every week, or one 100-gram tube every 2 weeks.
How much does Opzelura (ruxolitinib) cost?
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Opzelura (brand)
$0.00
What are alternatives to Opzelura (ruxolitinib)?
There are a number of medications that your doctor can prescribe in place of Opzelura (ruxolitinib). Compare a few possible alternatives below.
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