Prescription medicine
Upadacitinib Brand names: Rinvoq
Upadacitinib (Rinvoq) is a prescription medicine with an FDA approval on record since 2019. No generic is listed; pharmacies paid $229.31 per Rinvoq ER 15 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the upadacitinib FDA label on DailyMed (effective June 30, 2026, AbbVie Inc.); the NDA 211675 record on Drugs@FDA; every upadacitinib label on DailyMed.
Highlights of the record
FDA label of June 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS,.
and THROMBOSIS SERIOUS INFECTIONS Patients treated with RINVOQ /RINVOQ LQ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ /RINVOQ LQ until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before RINVOQ /RINVOQ LQ use and during therapy. Treatment for latent infection should be considered prior to RINVOQ /RINVOQ LQ use. Invasive fungal infections, including cryptococcosis and pneumocystosis. Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens. The risks and benefits of treatment with RINVOQ /RINVOQ LQ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. […]
Used for
From the label: indications and usageRINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor.
Forms and strengths
- 15 mg
- 30 mg
- 45 mg
- 1 mg/ml
Extended-release tablet; solution.
On the market
- Earliest approval on file
- August 16, 2019 Rinvoq, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 9, 2038 Rinvoq tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $229.31 per tablet Rinvoq ER 15 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 81,041 through July 30, 2026
What is upadacitinib used for?
From the label: indications and usageRINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor. RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ( 1.1 ) Limitations of Use RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.1 ) RINVOQ/RINVOQ LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. […]
Conditions named in the indications of upadacitinib's FDA labels, with every medicine labeled for each:
From other upadacitinib labelsRheumatoid arthritis: Rheumatoid Arthritis RINVOQ ® is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
Crohn's disease and ulcerative colitis: Ulcerative Colitis RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers.
FDA pharmacologic class: Janus Kinase Inhibitor.
Source: FDA drug label (Rinvoq), AbbVie Inc., effective June 30, 2026 (SPL set 2966aec7-2ef0-923c-d8ff-fe1a957bf095), via openFDA; the full label on DailyMed
What does the patient leaflet for upadacitinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about RINVOQ/RINVOQ LQ?RINVOQ/RINVOQ LQ can cause serious side effects, including: 1. Serious Infections. RINVOQ/RINVOQ LQ is a medicine that affects your immune system. RINVOQ/RINVOQ LQ can lower the ability of your immune system to fight infections. Some people have had serious infections while taking RINVOQ, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting treatment with RINVOQ/RINVOQ LQ. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with RINVOQ/RINVOQ LQ. You should not start taking RINVOQ/RINVOQ LQ if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). Before starting RINVOQ/RINVOQ LQ, tell your healthcare provider if you: ○ are being treated for an infection. ○ have had an infection that does not go away or that keeps coming back. ○ have diabetes, chronic lung disease, HIV, or a weak immune system. ○ have TB or have been in close contact with someone with TB. ○ have had shingles (herpes zoster). ○ have or have had hepatitis B or C. ○ live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use RINVOQ/RINVOQ LQ. […]
From the patient leaflet: What should I avoid while taking RINVOQ /RINVOQ LQ ?Avoid food or drink containing grapefruit during treatment with RINVOQ/RINVOQ LQ. Eating grapefruit or drinking grapefruit juice may increase the risk of side effects.
From the patient leaflet: How should I store RINVOQ /RINVOQ LQ ?Store RINVOQ tablets between 36°F to 77°F (2°C to 25°C). Store RINVOQ tablets in the original bottle to protect from moisture. Store RINVOQ LQ between 36°F to 86°F (2°C to 30°C). Throw away (discard) remaining RINVOQ LQ 60 days after opening the bottle. Keep RINVOQ /RINVOQ LQ and all medicines out of the reach of children.
Source: FDA drug label (Rinvoq), AbbVie Inc., effective June 30, 2026 (SPL set 2966aec7-2ef0-923c-d8ff-fe1a957bf095), via openFDA; the full label on DailyMed
Is there a generic for upadacitinib (Rinvoq)?
No generic upadacitinib is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 45 patents for Rinvoq tablets: the compound patent runs to October 17, 2036, and the last listed entry to March 9, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for upadacitinib (Rinvoq)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $229.31 per Rinvoq ER 15 mg tablet, up 5% from $218.34 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Rinvoq ER 30 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Rinvoq ER 15 mg tablet | Brand | $229.31 per tablet | $6,879.27 | +5% |
| Rinvoq ER 30 mg tablet | Brand | $229.29 per tablet | $6,878.82 | +5% |
| Rinvoq ER 45 mg tablet | Brand | $459.62 per tablet | $13,788.67 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the upadacitinib label say about other medicines?
The upadacitinib label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name upadacitinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clarithromycin | drug interactions | Upadacitinib exposure is increased when it is co-administered with a strong CYP3A4 inhibitor (such as ketoconazole, clarithromycin, and grapefruit), which may increase the risk of adverse reactions [see Clinical Pharmacology ( 12.3 )]. |
| Ketoconazole | drug interactions | Upadacitinib exposure is increased when it is co-administered with a strong CYP3A4 inhibitor (such as ketoconazole, clarithromycin, and grapefruit), which may increase the risk of adverse reactions [see Clinical Pharmacology ( 12.3 )]. |
| Methotrexate | boxed warning | Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. |
| Rifampin | drug interactions | Upadacitinib exposure is decreased when it is co-administered with strong CYP3A4 inducers (such as rifampin), which may lead to reduced therapeutic effect [see Clinical Pharmacology ( 12.3 )]. |
Other labels that name upadacitinib
Source: FDA drug label (Rinvoq), AbbVie Inc., effective June 30, 2026 (SPL set 2966aec7-2ef0-923c-d8ff-fe1a957bf095), via openFDA; the full label on DailyMed
What do FAERS reports show for upadacitinib?
The FDA Adverse Event Reporting System holds 81,041 reports that list upadacitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,016 are coded as a death and 20,108 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (17,234, against a median of 2,841 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as upadacitinib?
10 other medicines are given the same way (oral) and in the same FDA class as upadacitinib or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tofacitinib | Rheumatoid arthritis, Crohn's disease and ulcerative colitis | 24 labelers | $0.573 per tablet 5 mg tablet | No current entry |
| Baricitinib | Rheumatoid arthritis | none listed | $92.54 per tablet 2 mg tablet | No current entry |
| Indomethacin | Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
| Hydroxychloroquine | Rheumatoid arthritis | 28 labelers | $0.149 per tablet 200 mg tablet | A presentation being discontinued |
| Leflunomide | Rheumatoid arthritis | 16 labelers | $0.324 per tablet 10 mg tablet | A presentation being discontinued |
| Methotrexate | Rheumatoid arthritis | 25 labelers | $0.158 per tablet 2.5 mg tablet | In shortage |
| Sulfasalazine | Rheumatoid arthritis, Crohn's disease and ulcerative colitis | 5 labelers | $0.199 per tablet 500 mg tablet | No current entry |
| Penicillamine | Rheumatoid arthritis | 9 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as upadacitinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to upadacitinib
- 10 medicines for the same use
- Other janus kinase inhibitors
- the pharmacologic class, with prices and generics
- Upadacitinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other