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ruxolitinib topical

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Brand names: Opzelura

JAK Inhibitor (Topical) Rx

Opzelura is a cream that contains ruxolitinib. It is used on the skin to treat certain skin conditions.

Drug Pricing (NADAC)

Brand Price

$32.82/unit

Generic Available

No

INCYTE CORP

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Opzelura treats mild to moderate atopic dermatitis (eczema) in adults and children 2 years and older.

Common side effects

Common cold, Diarrhea, Bronchitis

Key warnings

Opzelura may increase your risk of serious infections, cancer, blood clots, and major heart problems.

How It Works

Opzelura contains a medicine called a Janus kinase (JAK) inhibitor. It works by blocking certain proteins in your body. These proteins are part of the process that causes skin inflammation and color loss.

How to Take It

Apply a thin layer of Opzelura to the affected skin twice a day. For eczema, only use on up to 20% of your body. For vitiligo, only use on up to 10% of your body. Do not cover the treated area with bandages. For eczema, stop using Opzelura when your skin clears up. If your eczema does not improve after 8 weeks, talk to your doctor.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. Opzelura may harm your unborn baby. You should not breastfeed while using Opzelura.

Missed Dose

If you miss a dose, apply it as soon as you remember. Then, continue with your regular schedule.

Storage

Store Opzelura at room temperature, between 68°F to 77°F.

Serious Warnings

Opzelura may increase your risk of serious infections, cancer, blood clots, and major heart problems. Contact your doctor immediately if you develop any signs or symptoms of an infection, such as fever, cough, or sore throat. Tell your doctor if you have ever had tuberculosis, as it could become active again. If you have a heart attack or stroke, stop using Opzelura.

Common Questions

Can I use Opzelura with other skin medicines?
Talk to your doctor before using Opzelura with other skin medicines, especially strong immunosuppressants.
How long does it take for Opzelura to work?
It may take several weeks to see improvement. If you do not see improvement after 8 weeks for eczema or 24 weeks for vitiligo, talk to your doctor.
Can I use Opzelura on any part of my body?
No, do not use Opzelura in your eyes, mouth, or vagina. Only use it on the affected skin areas.
What should I do if I get a skin infection while using Opzelura?
Tell your doctor right away if you think you have a skin infection.
Can children use Opzelura?
Yes, Opzelura can be used in children 2 years and older for eczema and 12 years and older for vitiligo.
Is it okay to smoke while using Opzelura?
No. Patients who are current or past smokers are at additional increased risk of major adverse cardiovascular events.
What are the symptoms of thrombosis?
Symptoms of thrombosis include pain and swelling in your legs, sudden chest pain, or shortness of breath.
Can I get a skin cancer from using Opzelura?
Yes, basal cell and squamous cell carcinoma have occurred. Perform periodic skin examinations during and following treatment.
What should I do if I have an active, serious infection?
Avoid use of OPZELURA in patients with an active, serious infection, including localized infections.
What should I do if I have a serious infection?
If a serious infection develops, interrupt OPZELURA until the infection is controlled.
What are the common side effects of ruxolitinib topical?
The most commonly reported side effects of ruxolitinib topical include Common cold, Diarrhea, Bronchitis, Ear infection, Increased eosinophil count. Always consult your healthcare provider about potential side effects.
What drug class is ruxolitinib topical?
ruxolitinib topical belongs to the JAK Inhibitor (Topical) drug class. It requires a prescription (Rx). Opzelura treats mild to moderate atopic dermatitis (eczema) in adults and children 2 years and older.
Is ruxolitinib topical safe during pregnancy?
Tell your doctor if you are pregnant or plan to become pregnant. Opzelura may harm your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for ruxolitinib topical

The FDA label for ruxolitinib topical (sold under brand names such as Opzelura) classifies it as a prescription-only medication in the JAK Inhibitor (Topical) class. Opzelura treats mild to moderate atopic dermatitis (eczema) in adults and children 2 years and older. Official labeling lists 19 commonly reported side effects, including Common cold, Diarrhea, Bronchitis.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: November 11, 2025

All federal data sources used on this page