Upadacitinib
Upadacitinib (Rinvoq) is a prescription JAK inhibitor used to treat several inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, and Crohn's 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Upadacitinib carries the FDA's most serious warning — a boxed warning — covering five major risks:
Serious infections: This drug lowers your immune defenses. Life-threatening infections, including tuberculosis, invasive fungal infections, and bacterial or viral infections, have occurred. You must be tested for TB before starting. Watch for fever, chills, cough, or any signs of infection.
Higher risk of death: In a large study of a similar JAK inhibitor in RA patients 50 and older with at least one heart risk factor, more deaths (including sudden cardiac death) occurred compared to patients on TNF blocker therapy.
Cancer (malignancy): Lymphoma and other cancers have been reported. Smokers and former smokers face even higher risk. Report any new lumps or unexplained symptoms to your doctor.
Major heart events: Heart attacks and strokes occurred at higher rates with a related JAK inhibitor compared to TNF blockers, particularly in older RA patients with cardiovascular risk factors.
Blood clots (thrombosis): Serious clots in the legs, lungs, and arteries have been reported. Seek immediate care for sudden leg swelling, chest pain, or difficulty breathing.
📖 Upadacitinib: Patient Information Guide
A plain-language walkthrough of Upadacitinib — 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▾
Upadacitinib (Rinvoq / Rinvoq LQ) treats several moderate-to-severe inflammatory conditions in adults and some children:
- Rheumatoid arthritis (RA) — adults who haven't responded to TNF blocker therapy
- Psoriatic arthritis — adults and children 2 years and older with an inadequate response to TNF blockers
- Atopic dermatitis (eczema) — people 12 and older whose disease isn't controlled by other systemic treatments, including biologics
- Ulcerative colitis — adults who haven't responded to TNF blockers or other approved systemic therapy
- Crohn's disease — adults who haven't responded to TNF blockers or other approved systemic therapy
⚙️How it works▾
Your immune system uses proteins called JAK enzymes (Janus kinases) to send inflammatory signals from cell to cell. In conditions like RA or Crohn's disease, those signals get stuck in overdrive. Upadacitinib works by blocking JAK1 and JAK2 inside immune cells, interrupting that signal chain and calming the overactive inflammation that causes pain, swelling, and tissue damage.
It reaches peak effect on those enzymes within about an hour of a dose, and the body clears it within the same day — which means consistent daily dosing keeps the inflammation control steady.
💊How it's taken▾
Upadacitinib is taken once daily by mouth. The tablet form (Rinvoq extended-release) can be taken with or without food. The oral solution (Rinvoq LQ) is also not significantly affected by food. The two forms are not interchangeable dose-for-dose — your healthcare provider decides which one is right for you and whether any switch is needed.
- For some conditions (like ulcerative colitis and Crohn's disease), a higher induction dose is used for the first several weeks, then stepped down to a lower maintenance dose
- For atopic dermatitis in some patients, the dose may be increased if the initial dose doesn't work well enough
- If you have severe kidney or liver problems, your dose may need adjustment
Always take it exactly as prescribed. If you miss a dose, follow the instructions on your label or call your pharmacist.
🤒Side effects — in detail▾
The most common side effects reported across conditions include:
- Upper respiratory infections (colds, sinus infections)
- Acne
- Herpes zoster (shingles) or herpes simplex flares
- Headache
- Nausea
- Cough and fatigue
- Folliculitis (inflamed or infected hair follicles)
- Changes in blood counts or liver enzymes (found on lab tests)
Seek medical attention right away for signs of serious infection (fever, chills, difficulty breathing), symptoms of a blood clot (leg swelling, chest pain), signs of a heart attack or stroke, or a severe allergic reaction (throat swelling, hives, difficulty breathing).
⚠️Warnings & precautions▾
Upadacitinib's most critical risks are outlined in a boxed warning — the FDA's highest-level alert:
- Serious infections, including TB and fungal infections: Screening is required before you start. Interrupt treatment if a serious infection develops.
- Increased mortality: A related JAK inhibitor showed higher all-cause death rates, including sudden cardiac death, compared to TNF blockers in older RA patients with heart risk factors.
- Cancer risk: Lymphoma and other malignancies have been reported. Smokers face additional risk.
- Major heart events: Heart attack and stroke occurred more often with a JAK inhibitor vs. TNF blockers in high-risk RA patients.
- Blood clots (thrombosis): Clots in leg veins, lungs, and arteries have been reported.
- Fetal harm: Animal studies show risk to a developing baby. Effective contraception is required for people who can become pregnant.
- GI (stomach/intestinal) perforations: Tears in the gut wall have been reported; report sudden severe abdominal pain immediately.
- Live vaccines: Avoid while on this medication.
🔀What it interacts with▾
Upadacitinib is broken down mainly by a liver enzyme called CYP3A4. Drugs or foods that affect this enzyme can change how much upadacitinib is in your system:
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) — raise upadacitinib blood levels, increasing side effect risk; dose reduction may be needed for some conditions
- Grapefruit and grapefruit juice — also inhibits CYP3A4; avoid entirely during treatment
- Strong CYP3A4 inducers (e.g., rifampin) — lower upadacitinib levels and reduce effectiveness; combination is not recommended
- Other JAK inhibitors or biologic DMARDs — not recommended in combination; raises immune suppression risk
- Potent immunosuppressants (e.g., azathioprine, cyclosporine) — not recommended in combination
- Live vaccines — avoid; the immune-suppressing effect of upadacitinib may make live vaccines unsafe or less effective
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 or chronic infections: Do not start if you have an active serious infection; discuss any history of recurring infections with your doctor
- Tuberculosis: Must be tested (and treated if latent TB is found) before starting
- Pregnancy: Animal data shows fetal harm; use effective contraception; report pregnancy to your doctor and enroll in the pregnancy surveillance program (1-800-633-9110)
- Breastfeeding: Not recommended while taking upadacitinib
- Severe liver impairment: Not recommended
- Severe kidney impairment: A lower dose is recommended; your provider will guide this
- Age 50+ with cardiovascular risk factors: Higher risk of heart events, cancer, and death compared to TNF blocker therapy — discuss carefully with your doctor
- Current or former smokers: At additional increased risk for malignancy
- Low blood counts: Treatment should not be started or should be paused if lymphocyte, neutrophil, or hemoglobin levels fall below certain thresholds
- Known allergy to upadacitinib or any ingredient in Rinvoq: Do not take this medication
📡Pharmacodynamics — effects in the body▾
Upadacitinib starts blocking JAK enzyme activity quickly — in healthy volunteers, maximum suppression of certain inflammatory signals was seen about 1 hour after a dose, returning to near-baseline by the end of the dosing period. In RA patients, white blood cell (lymphocyte) counts showed a small, temporary rise early in treatment that gradually returned to normal with continued use. Small decreases in certain antibody levels (IgG and IgM) were observed but stayed within the normal range. At doses well above the highest therapeutic dose, upadacitinib did not cause any meaningful effect on the heart's electrical rhythm (QTc interval).
🔬Pharmacokinetics — how your body processes it▾
After you take the extended-release tablet, upadacitinib is absorbed within about 2 to 4 hours, reaching steady, stable blood levels within 4 days of daily dosing. Food doesn't meaningfully affect how well the tablet works. The drug is about 52% bound to proteins in the blood, and it is broken down mainly by a liver enzyme called CYP3A4, with the parent drug being the active form. The oral solution reaches peak levels faster (about 1 hour) than the tablet, and the two forms are not interchangeable dose-for-dose because they deliver different exposures.
📦How to store it▾
RINVOQ extended-release tablets Store at 2˚C to 25˚C (36˚F to 77˚F). Store in the original bottle in order to protect from moisture. Store between 2°C to 30°C (36°F to 86°F).
📄 Written from Upadacitinib’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 Upadacitinib
138 supplements and herbal products have documented interactions with Upadacitinib 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 · 94
- Minor · 41
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 Upadacitinib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Rinvoq supposed to do for me? ▾
How do I take it — does it matter if I take it with food? ▾
What side effects should I watch for, and when do I need to call the doctor? ▾
I've heard this drug has serious risks. Should I be worried? ▾
Can I take this if I'm pregnant or planning to become pregnant? ▾
Are there foods or other medications I need to avoid? ▾
Is Upadacitinib available over the counter? ▾
When was Upadacitinib first available? ▾
Who makes Upadacitinib? ▾
💬 Answers drafted from Upadacitinib’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 Upadacitinib comes
Upadacitinib 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.
📊 Upadacitinib across the U.S. market
How Upadacitinib 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 (7) — 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 Upadacitinib is used
A general measure of how commonly Upadacitinib 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 Upadacitinib 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 Upadacitinib prescribed? Of the 1,597 medications we measure, Upadacitinib ranks #498 by Medicaid prescriptions — more than 69% of them.
Utilization by Upadacitinib 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.
24 HR upadacitinib 15 MG Extended Release Oral Tablet Most dispensed
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2196894
24 HR upadacitinib 30 MG Extended Release Oral Tablet
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2590051
24 HR upadacitinib 45 MG Extended Release Oral Tablet
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2596957
upadacitinib 1 MG/ML Oral Solution
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2681015
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 Upadacitinib, 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 4 of 14 listed Upadacitinib NDCs with Medicaid activity.
🔍 Compare Upadacitinib products
A representative set of FDA-listed product records for Upadacitinib — 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 | ||||
| 15 mg | Oral | AbbVie Inc. × 4 listings | NDA | View NDC → |
| 30 mg | Oral | AbbVie Inc. × 4 listings | NDA | View NDC → |
| 30 mg | — | AbbVie Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 45 mg | Oral | AbbVie Inc. × 4 listings | NDA | View NDC → |
| 💊Oral solution | ||||
| 1 mg/mL | Oral | AbbVie Inc. × 2 listings | NDA | View NDC → |
| 💊Tablet | ||||
| 15 mg | — | AbbVie Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 45 mg | — | AbbVie Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 15 mg | — | AbbVie Ireland NL B.V. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 30 mg | — | AbbVie Ireland NL B.V. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 45 mg | — | AbbVie Ireland NL B.V. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | AbbVie Ireland NL B.V. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | AbbVie SRL | BULK INGREDIENT | View NDC → |
| 50 kg/50 kg | — | Aurobindo Pharma Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Curia Spain S.A.U. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Honour Lab Limited | BULK INGREDIENT | View NDC → |
| 0.5 kg/0.5 kg | — | Metrochem Api Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
Showing 27 of 27 products — FDA National Drug Code Directory. See every product, package size and price: browse all 27 Upadacitinib 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 Upadacitinib — 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 Upadacitinib 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 Upadacitinib 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 2196092 2 dose forms · 4 strengths
-
Dose form (SCDF) Extended Release Oral Tablet RxCUI 2196893In current FDA listingsClinical drug / strength (SCD) 24 HR upadacitinib 15 MGRxCUI 219689424 HR upadacitinib 30 MGRxCUI 259005124 HR upadacitinib 45 MGRxCUI 2596957 -
Dose form (SCDF) Oral Solution RxCUI 2681014In current FDA listingsClinical drug / strength (SCD) 1 MG/MLRxCUI 2681015
Look up RxCUI 2196092 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 Upadacitinib 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
Upadacitinib belongs to the Janus 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. AbbVie Inc. 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.