ruxolitinib topical
Brand names: Opzelura
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?
How long does it take for Opzelura to work?
Can I use Opzelura on any part of my body?
What should I do if I get a skin infection while using Opzelura?
Can children use Opzelura?
Is it okay to smoke while using Opzelura?
What are the symptoms of thrombosis?
Can I get a skin cancer from using Opzelura?
What should I do if I have an active, serious infection?
What should I do if I have a serious infection?
What are the common side effects of ruxolitinib topical?
What drug class is ruxolitinib topical?
Is ruxolitinib topical safe during pregnancy?
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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
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages