Ruxolitinib
Ruxolitinib (Jakafi) is a targeted oral medication used to treat certain bone marrow disorders and graft-versus-host disease.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Ruxolitinib: Patient Information Guide
A plain-language walkthrough of Ruxolitinib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Ruxolitinib is used to treat several serious conditions involving the blood, bone marrow, or immune system:
- Myelofibrosis (MF) — including primary MF, and MF that developed after polycythemia vera or essential thrombocythemia (intermediate or high-risk disease, in adults)
- Polycythemia vera (PV) — in adults whose disease did not respond well to hydroxyurea, or who could not tolerate it
- Acute graft-versus-host disease (aGVHD) — in adults and patients 12 and older whose condition did not respond to steroids
- Chronic graft-versus-host disease (cGVHD) — in adults and patients 12 and older after one or two other systemic treatments have failed
⚙️How it works▾
Ruxolitinib targets a pair of enzymes called JAK1 and JAK2 (Janus kinases). Think of these as internal relay switches: they receive signals from outside the cell and pass them along to activate genes that control cell growth, blood production, and inflammation. In diseases like myelofibrosis and polycythemia vera, these switches are overactive — driving out-of-control cell production and chronic inflammation. By blocking JAK1 and JAK2, ruxolitinib turns down that overactive signal, helping to normalize blood cell production and reduce inflammation. In graft-versus-host disease, the same JAK signaling pathway drives the immune attack on the recipient's own tissue; blocking it helps calm that response.
💊How it's taken▾
Ruxolitinib is taken by mouth in tablet form. The standard version (Jakafi) is generally taken twice a day; the extended-release version (Jakafi XR) is taken once a day. Both can be taken with or without food — meals do not meaningfully affect how the drug is absorbed.
- Your exact dose depends on your condition and, for myelofibrosis, your platelet count — doses are individualized and may be adjusted over time
- Do not stop taking it suddenly without your doctor's guidance — abrupt discontinuation can cause your symptoms to flare
- Follow your prescriber's instructions and the label on your prescription exactly
🤒Side effects — in detail▾
The most common side effects vary somewhat by condition, but overall include:
- Thrombocytopenia (low platelet count) — increases bruising and bleeding risk
- Anemia (low red blood cell count) — can cause fatigue and weakness
- Neutropenia (low white blood cell count) — raises infection risk
- Bruising more easily than usual
- Dizziness
- Headache
- Diarrhea
- Swelling (edema) — especially in GVHD patients
Serious reactions to watch for include signs of infection (fever, chills), chest pain or stroke symptoms, unusual skin changes, or signs of blood clots — call your doctor or get emergency help if any of these occur.
⚠️Warnings & precautions▾
- Serious infections — including tuberculosis, fungal, viral (e.g., shingles), and bacterial infections. Screening before starting is essential; report any signs of infection immediately during treatment.
- Blood count drops — low platelets, red cells, and white cells are common. Regular blood tests (CBC) every 2–4 weeks early on are required.
- Stopping suddenly — abrupt discontinuation can cause rapid return or worsening of disease symptoms. Taper or resume only under medical supervision.
- Cardiovascular events and mortality — in patients with heart disease risk factors, JAK inhibitors have been linked to higher rates of heart attack, stroke, and death.
- Blood clots (thrombosis) — deep vein clots, pulmonary embolism, and other clotting events have been reported. Seek immediate care for sudden leg swelling, chest pain, or trouble breathing.
- Cancer risk — lymphoma, non-melanoma skin cancer, and other malignancies have been reported. Periodic skin exams and monitoring for new symptoms are recommended, especially in current or former smokers.
- Elevated cholesterol — lipid levels should be checked 8–12 weeks after starting therapy.
🔀What it interacts with▾
Ruxolitinib is processed by liver enzymes (mainly CYP3A4), so drugs that affect those enzymes can change how much ruxolitinib is in your bloodstream:
- Fluconazole (antifungal) — raises ruxolitinib blood levels significantly; avoid higher doses of fluconazole, and your ruxolitinib dose may need to be reduced even with lower doses
- Strong CYP3A4 inhibitors (e.g., certain antifungals, some antibiotics, some HIV medications) — increase ruxolitinib exposure and the risk of side effects; dose reduction is usually needed (except in GVHD patients, per your doctor's guidance)
- Strong CYP3A4 inducers (e.g., certain anti-seizure drugs, rifampin for tuberculosis) — lower ruxolitinib levels, potentially making it less effective; close monitoring and possible dose adjustment is needed
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Active infections: Do not start ruxolitinib until any serious infection has fully resolved
- Past infections: Tell your doctor about any history of tuberculosis, herpes, hepatitis B, or recurring infections — screening is required before starting
- Kidney impairment: A lower starting dose or avoiding use may be needed — discuss with your doctor
- Liver impairment: Dose reduction may be required — your doctor will assess this
- Pregnancy: Animal studies showed developmental harm at high doses. There are no human studies. Discuss risks and benefits carefully with your doctor if you are pregnant or planning to become pregnant
- Breastfeeding: Do not breastfeed while taking ruxolitinib — it is unknown whether it passes into breast milk, but the potential risk to an infant means breastfeeding should be avoided
- Smokers (current or former): Face an additional increased risk of malignancy — be sure your doctor knows your smoking history
- Patients 12 and older: Approved for GVHD in this age group; dosing should be guided by the prescriber
🚑If you take too much▾
There is no specific antidote if too much ruxolitinib is taken. Taking more than prescribed can worsen bone marrow suppression — meaning dangerously low counts of red blood cells, white blood cells, and platelets. If an overdose is suspected, supportive medical treatment should be provided; hemodialysis (kidney dialysis) is not expected to help remove the drug from the body.
📡Pharmacodynamics — effects in the body▾
After dosing, ruxolitinib reaches its peak effect on JAK-STAT signaling (a key cell communication pathway) within about 2 hours, with the effect returning close to baseline by 10 hours. This means the drug is actively working against its target for several hours after each dose. At recommended doses, ruxolitinib does not cause any clinically meaningful changes to heart rhythm (specifically, it does not prolong the QT interval — an electrical measurement of the heart).
🔬Pharmacokinetics — how your body processes it▾
Ruxolitinib is very well absorbed when taken by mouth — at least 95% of a dose enters the bloodstream, and food does not meaningfully affect this. The standard tablet reaches peak blood levels in about 1–2 hours; the extended-release version peaks around 3 hours. The drug reaches a stable level in the blood (steady state) within about 3 days of regular dosing. It is broken down mainly by the liver enzyme CYP3A4, and most of the drug is excreted in the urine. The half-life (how long it takes the body to clear half the drug) is approximately 3 hours for the standard form, though the combined effect of the drug and its active metabolites lasts roughly 5–6 hours.
📦How to store it▾
Store JAKAFI/JAKAFI XR at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) . Dispense in a tight container. Protect from light.
📄 Written from Ruxolitinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Ruxolitinib
141 supplements and herbal products have documented interactions with Ruxolitinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 96
- Minor · 42
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Ruxolitinib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is ruxolitinib treating in my body? ▾
Can I stop taking it if I feel better or if the side effects bother me? ▾
What signs of infection should I watch for while I'm on this medication? ▾
I take fluconazole sometimes for yeast infections. Is that a problem? ▾
Is it safe to take ruxolitinib if I'm pregnant or trying to get pregnant? ▾
I'm a former smoker. Does that change anything about my risk on this drug? ▾
Is Ruxolitinib available over the counter? ▾
When was Ruxolitinib first available? ▾
Who makes Ruxolitinib? ▾
💬 Answers drafted from Ruxolitinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Ruxolitinib comes
Ruxolitinib is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
Extended-release tablet
Topical cream, ointment or gel
📊 Ruxolitinib across the U.S. market
How Ruxolitinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (21) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Ruxolitinib is used
A general measure of how commonly Ruxolitinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ruxolitinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ruxolitinib prescribed? Of the 1,596 medications we measure, Ruxolitinib ranks #534 by Medicaid prescriptions — more than 67% of them.
Utilization by Ruxolitinib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
ruxolitinib 15 MG/ML Topical Cream Most dispensed
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2570752
ruxolitinib 10 MG Oral Tablet
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1193331
ruxolitinib 5 MG Oral Tablet
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1193339
ruxolitinib 20 MG Oral Tablet
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1193347
ruxolitinib 15 MG Oral Tablet
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1193343
ruxolitinib 25 MG Oral Tablet
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1193351
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ruxolitinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 20 listed Ruxolitinib NDCs with Medicaid activity.
🔍 Compare Ruxolitinib products
A representative set of FDA-listed product records for Ruxolitinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Extended-release tablet | ||||
| 11 mg | Oral | Incyte Corporation × 2 listings | NDA | View NDC → |
| 22 mg | Oral | Incyte Corporation × 2 listings | NDA | View NDC → |
| 33 mg | Oral | Incyte Corporation × 2 listings | NDA | View NDC → |
| 44 mg | Oral | Incyte Corporation × 2 listings | NDA | View NDC → |
| 55 mg | Oral | Incyte Corporation × 2 listings | NDA | View NDC → |
| 💊Tablet | ||||
| 5 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 10 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 15 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 20 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 25 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 5 mg | Oral | Incyte Corporation × 4 listings | NDA | View NDC → |
| 10 mg | Oral | Incyte Corporation × 4 listings | NDA | View NDC → |
| 15 mg | Oral | Incyte Corporation × 4 listings | NDA | View NDC → |
| 20 mg | Oral | Incyte Corporation × 4 listings | NDA | View NDC → |
| 25 mg | Oral | Incyte Corporation × 4 listings | NDA | View NDC → |
| 5 mg | — | Patheon Manufacturing Services LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 10 mg | — | Patheon Manufacturing Services LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 15 mg | — | Patheon Manufacturing Services LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 20 mg | — | Patheon Manufacturing Services LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 25 mg | — | Patheon Manufacturing Services LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Topical cream, ointment or gel | ||||
| 15 mg/g | Topical | Incyte Corporation × 4 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Alivus Life Sciences Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | American Pacific Corporation × 3 listings | BULK INGREDIENT | View NDC → |
| 1 g/g | — | AX Pharmaceutical Corp | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Chongqing Huapont Pharmaceutical Co., Ltd | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Chunghwa Chemical Synthesis & Biotech Co., Ltd. × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Finorga | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Granules India Limited × 2 listings | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1 g/g | — | Melody Healthcare Pvt. Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited × 3 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Natco Pharma Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Siegfried Evionnaz SA | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Sterling Spa | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Valary Lab Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Zhejiang Ausun Pharmaceutical Co., Ltd. × 2 listings | BULK INGREDIENT | View NDC → |
Showing 65 of 65 products — FDA National Drug Code Directory. See every product, package size and price: browse all 65 Ruxolitinib NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ruxolitinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ruxolitinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Ruxolitinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1193326 3 dose forms · 11 strengths
-
Dose form (SCDF) Extended Release Oral Tablet RxCUI 2743011In current FDA listingsClinical drug / strength (SCD) 24 HR ruxolitinib 11 MGRxCUI 274301224 HR ruxolitinib 22 MGRxCUI 274301924 HR ruxolitinib 33 MGRxCUI 274302524 HR ruxolitinib 44 MGRxCUI 274303224 HR ruxolitinib 55 MGRxCUI 2743041 -
Dose form (SCDF) Oral Tablet RxCUI 1193330In current FDA listings -
Dose form (SCDF) Topical Cream RxCUI 2570751In current FDA listingsClinical drug / strength (SCD) 15 MG/MLRxCUI 2570752
Look up RxCUI 1193326 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Ruxolitinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Ruxolitinib belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Incyte Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.