Ruxolitinib: uses, dosing, side effects & brands
Ruxolitinib is a janus kinase inhibitor sold in the U.S. under 3 brand and generic names, for polycythemia vera and primary myelofibrosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Janus Kinase Inhibitor
- Treats (across its forms)
- Polycythemia Vera and Primary Myelofibrosis
- Available as
- Tablet · Tablet, extended release · Topical
- Sold as
- 3 products — Jakafi, Jakafi XR and Opzelura
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How Opzelura is dosed
From the FDA label for Opzelura (application NDA215309). Other ruxolitinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Atopic Dermatitis Apply a thin layer of OPZELURA topically twice daily to affected areas of up to 20% body surface area. ( 2.1 ) Do not use OPZELURA with occlusive dressings. ( 2.1 ) Adult and Pediatric Patients 12 Years of Age and Older Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks. ( 2.1 ) Pediatric Patients 2 to 11 Years of Age Do not use more than one 60 gram tube of OPZELURA per 2 weeks. ( 2.1 ) Nonsegmental Vitiligo Apply a thin layer of OPZELURA topically twice daily to affected areas of up to 10% body surface area. ( 2.2 ) Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks. ( 2.2 ) 2.1 Recommended Dosage and Administration for Atopic Dermatitis OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use. Instruct patients to apply a thin layer of OPZELURA twice daily to affected areas of up to 20% body surface area. Do not use OPZELURA with occlusive dressings. Stop using when signs and symptoms (e.g., itch, rash, and redness) of atopic dermatitis resolve. If signs and symptoms do not improve within 8 weeks, patients should be re-examined by their healthcare provider [see Clinical Studies ( 14.1 )] . Adult and Pediatric Patients 12 Years of Age and Older Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks.…
Everything below is the FDA label for Opzelura (topical). Ruxolitinib is also sold as tablet and tablet, extended release, and those are different medicines to take — follow the label for the one you were prescribed.
Opzelura side effects
In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) are nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, rhinorrhea, upper respiratory tract infection, COVID-19, application site reactions, pyrexia, and white blood cell decreased. ( 6 ) In nonsegmental vitiligo, the most common adverse reactions (incidence ≥ 1%) are application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult and Pediatric Subjects 2 Years of Age and Older with Atopic Dermatitis Adult and Pediatric Subjects 12 Years of Age and Older In two double-blind, vehicle-controlled clinical trials (TRuE-AD1 and TRuE-AD2), 499 adult and pediatric subjects 12 years of age and older with atopic dermatitis were treated topically with OPZELURA twice daily for 8 weeks [see Clinical Studies ( 14.1 )] .…
Who shouldn’t take Opzelura
None. None. ( 4 )
Opzelura drug interactions
Drug interaction studies with OPZELURA have not been conducted. Ruxolitinib is known to be a substrate for cytochrome P450 3A4 (CYP3A4). Inhibitors of CYP3A4 may increase ruxolitinib systemic concentrations whereas inducers of CYP3A4 may decrease ruxolitinib systemic concentrations [see Clinical Pharmacology ( 12.3 )] . Strong Inhibitors of CYP3A4 Avoid concomitant use of OPZELURA with strong inhibitors of CYP3A4 as there is a potential to increase the systemic exposure of ruxolitinib and could increase the risk of OPZELURA adverse reactions [see Clinical Pharmacology ( 12.3 )] .
Every ruxolitinib product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Tablet | No data | — | View → | |
| 2 | Not yet rated | Prescription | Tablet | No data | — | View → | |
| 3 | Not yet rated | Prescription | Topical | No data | — | View → |
Ruxolitinib and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for ruxolitinib: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of ruxolitinib during breastfeeding. Because ruxolitinib is 97% bound to plasma proteins, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be discontinued during ruxolitinib therapy and for 2 weeks after the last dose for the oral tablets and for 4 weeks after the last dose for the topical cream. However, ruxolitinib cream is approved for direct application in children as young as 2 years of age.
National Institute of Child Health and Human Development, record revised December 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about ruxolitinib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 278 reports naming ruxolitinib, and the FDA flagged 94% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- sepsis45 reports
- multiple organ dysfunction syndrome34 reports
- treatment failure34 reports
- acute graft versus host disease33 reports
- adenovirus infection32 reports
- stenotrophomonas infection31 reports
- thrombocytopenia22 reports
- neutropenia20 reports
Read these as a signal, not a rate. A report does not mean ruxolitinib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 26, 2026.
Related calculators
Frequently asked questions
What is Opzelura?
Opzelura (Ruxolitinib Phosphate) is a janus kinase inhibitor used to treat Polycythemia Vera, Primary Myelofibrosis.
What kind of drug is ruxolitinib?
The FDA classifies ruxolitinib as a janus kinase inhibitor. JAK inhibitors block Janus kinase enzymes inside immune cells. These enzymes normally pass along messages from inflammatory signals (cytokines) to relay proteins that switch on genes, so blocking them turns down the overactive immune signaling that drives diseases like rheumatoid arthritis. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take ruxolitinib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ruxolitinib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is ruxolitinib sold under?
We track 3 ruxolitinib-containing products in the U.S.: Jakafi, Jakafi XR and Opzelura. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does ruxolitinib come in?
Across the brands we track, ruxolitinib is currently marketed as tablet, tablet, extended release and topical, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic ruxolitinib?
We do not currently list a generic-labelled ruxolitinib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Ruxolitinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ruxolitinib
- MLA
- “Ruxolitinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ruxolitinib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for ruxolitinib on DailyMed (NIH) ↗ — including its boxed warning in full.