Upadacitinib

Pronunciation: OO-pa-DAY-si-TI-nib.

Generic name
upadacitinib
Drug class
Janus kinase (JAK) inhibitor
Form
Extended/prolonged-release tablet (15 mg, 30 mg, 45 mg); oral solution (Rinvoq LQ, US, for patients who cannot swallow tablets)
Route
Oral
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Rinvoq (5) · Full directory

What upadacitinib is and how it works

Upadacitinib is an oral, once-daily Janus kinase (JAK) inhibitor that reduces inflammation by blocking specific signalling enzymes involved in the immune response. It is used across a broad range of inflammatory and autoimmune conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis (eczema), ulcerative colitis, Crohn's disease, and giant cell arteritis. (1) (2)

Because upadacitinib affects the immune system broadly, it carries a real, serious risk of infections, and -- as a class-wide finding across JAK inhibitor medicines -- an increased risk of certain cancers, major cardiovascular events, blood clots, and death in some patient groups. Your clinician will weigh these risks against the benefit for your specific condition, especially if you are 65 or older, have cardiovascular risk factors, or are a current or past smoker.

Mechanism of action: how upadacitinib works

Upadacitinib is a reversible, selective inhibitor of Janus kinase 1 (JAK1), reducing the signalling of multiple pro-inflammatory cytokines involved in the pathophysiology of the approved inflammatory and autoimmune conditions. (1) (2)

What upadacitinib is used for

Rheumatoid arthritis

For adults with moderately to severely active rheumatoid arthritis, alone or combined with methotrexate or another conventional DMARD. (1) (6)

Psoriatic arthritis

For adults with active psoriatic arthritis who have responded inadequately to, or cannot tolerate, one or more DMARDs; alone or with a non-biological DMARD. (2) (6)

Ankylosing spondylitis and non-radiographic axial spondyloarthritis

For adults with active disease who have responded inadequately to conventional therapy (ankylosing spondylitis) or who have objective signs of inflammation (non-radiographic axial spondyloarthritis). (6)

Atopic dermatitis (eczema)

For adults and adolescents 12 years and older with moderate to severe atopic dermatitis who are candidates for systemic therapy. (1) (6)

Ulcerative colitis and Crohn's disease

For adults with moderately to severely active disease who have had an inadequate response, lost response, or were intolerant to conventional therapy or a biologic agent. (6)

Giant cell arteritis

For adults with giant cell arteritis, typically alongside a corticosteroid taper. (1) (6)

Polyarticular juvenile idiopathic arthritis (United States)

For children 2 years and older with active polyarticular juvenile idiopathic arthritis, using weight-based dosing. (1)

Before taking upadacitinib

Do not take / not appropriate for

  • Do not take upadacitinib if you have a known serious allergic reaction to it or its ingredients. (all countries) (2)
  • Do not take upadacitinib if you have an active, serious infection, including tuberculosis. (all countries) (2) (6)
  • Do not take upadacitinib if you have severe liver impairment. (United Kingdom, European Union) (2)
  • Do not take upadacitinib if you are pregnant, or become pregnant while taking it -- it can cause fetal harm. (all countries) (2) (1)

Tell your clinician about

  • Any history of chronic or recurrent infection, tuberculosis exposure, or a serious/opportunistic infection.
  • Whether you have lived in or travelled to an area with endemic tuberculosis or endemic fungal infections.
  • Any history of cancer, or risk factors for cancer, including current or past long-term smoking.
  • Any history of heart disease, stroke, or risk factors for blood clots (such as a personal or family history of DVT/PE).
  • All other medicines, including whether you take a strong CYP3A4 inhibitor or inducer.
  • Whether you are pregnant, plan to become pregnant, or are breastfeeding.
  • Whether you have diabetes and take other medicines that can lower blood sugar.
(1) (2) (6)

How to take upadacitinib

  • Taken by mouth, with or without food, once daily.
  • Swallow the tablet whole. Do not split, crush, or chew it -- dose equivalence when the tablet is divided has not been established.
  • Take it at around the same time each day.
  • Do not stop or change your dose without talking to your clinician, even if you feel well -- your condition, dose, and monitoring plan are individualised.
(1) (2) (6)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, take it as soon as you remember unless it is almost time for your next dose -- in that case, skip the missed dose and continue your normal schedule. Do not take two doses at once. Contact your clinician or pharmacist if you are unsure.

Overdose

Seek urgent medical attention if you think you have taken too much upadacitinib, or contact a poison control service for guidance. Take the medicine packaging with you if you seek care. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Upper respiratory tract infections (common colds, sinus infections).

What to notice: Upper respiratory tract infections (common colds, sinus infections).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Nausea.

What to notice: Nausea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (6)

Headache.

What to notice: Headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Elevated blood lipids (cholesterol).

What to notice: Elevated blood lipids (cholesterol).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (6)

Cough.

What to notice: Cough.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (6)

Acne (with atopic dermatitis use).

What to notice: Acne (with atopic dermatitis use).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (6)

Serious warnings

Signs of a serious infection — boxed_warning

Symptoms: Fever, sweating, chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm/red/painful skin or sores on the body, feeling very tired, and diarrhoea or stomach pain.

Action: Contact your clinician promptly -- upadacitinib increases the risk of serious infections, including tuberculosis and fungal infections, that can lead to hospitalisation or death. Treatment may need to be paused until the infection is controlled. (1) (6)

Signs of a blood clot (thrombosis) — boxed_warning

Symptoms: Sudden swelling, pain, or tenderness in one leg; sudden shortness of breath or chest pain; coughing up blood.

Action: Seek emergency medical help immediately -- these can be signs of deep vein thrombosis or a pulmonary embolism, a real, boxed-warning-level risk with this medicine. (1) (6)

Signs of a major cardiovascular event (heart attack or stroke) — boxed_warning

Symptoms: Chest pain or pressure, pain spreading to the arm or jaw, shortness of breath, sudden weakness or numbness on one side of the body, sudden difficulty speaking, sudden severe headache.

Action: Seek emergency medical help immediately. This risk is treated with extra caution in people 65 or older, current/past smokers, or those with other cardiovascular risk factors. (1) (6)

Unusual lumps, unexplained weight loss, or other possible signs of cancer — boxed_warning

Symptoms: New or enlarging lumps or swollen glands, unexplained weight loss, night sweats, new skin lesions that change or do not heal.

Action: Report these to your clinician for prompt assessment -- upadacitinib carries an increased risk of lymphoma and other cancers, including non-melanoma skin cancer, which rises with the 30 mg dose compared with 15 mg. (2) (6)

Signs of a serious allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives.

Action: Seek emergency medical help immediately and stop taking upadacitinib. (1)

Signs of gastrointestinal perforation — high caution

Symptoms: Sudden, severe abdominal pain, fever, and significant changes in bowel habits, especially if you have diverticulitis.

Action: Seek urgent medical care -- this is a rare but serious event reported with upadacitinib. (1)

Interactions

  • Strong CYP3A4 inhibitors can raise upadacitinib levels; strong CYP3A4 inducers can lower its effectiveness -- tell your clinician about all other medicines. (6)
  • Live vaccines should be avoided during treatment -- discuss vaccination timing with your clinician before starting. (1)
  • Combining with other strong immunosuppressants (such as biologic DMARDs or other JAK inhibitors) is generally avoided because of an increased risk of infection. (2)
  • Upadacitinib can increase the effect of medicines that lower blood sugar, increasing hypoglycaemia risk in people with diabetes. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Contraindicated -- upadacitinib can cause fetal harm based on animal studies; effective contraception is recommended during treatment and for a period after stopping, per your clinician's guidance. (1) (2) (3) (4) (5) (6)

Breastfeeding

Not recommended during treatment; discuss timing and alternatives with your clinician. (1) (2) (3) (4) (5) (6)

Children

Approved from age 2 (juvenile idiopathic arthritis, US) or age 12 (atopic dermatitis, most markets) with weight-based or age-appropriate dosing; not established below these ages. (1) (2) (3) (4) (5) (6)

Elderly

Used with extra caution in people 65 and older, and in current or past long-term smokers, because of the higher observed rates of serious infection, malignancy, MACE, and mortality in this age group in the class-wide safety data; only used if no suitable alternative is available for higher-risk patients. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Contraindicated in severe hepatic impairment; dose adjustment or caution needed in moderate impairment per the treating clinician. (1) (2) (3) (4) (5) (6)

Renal_impairment

Used with monitoring; specific dose adjustment guidance is set by the treating clinician based on the degree of impairment. (1) (2) (3) (4) (5) (6)

Source_ids

US-DAILYMED-RINVOQ-2026,UK-EMC-RINVOQ-2026,NZ-MEDSAFE-RINVOQ-DS-2026 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Screening for latent or active tuberculosis
  • Baseline full blood count (neutrophils, lymphocytes, haemoglobin)
  • Baseline liver function tests and lipid profile
  • Assessment of infection, cancer, and cardiovascular risk factors
  • Pregnancy test where relevant

During treatment

  • Periodic blood count monitoring (neutrophils, lymphocytes, haemoglobin) as clinically indicated.
  • Lipid profile check around 12 weeks after starting, then per local hyperlipidaemia guidelines.
  • Liver enzyme monitoring as clinically indicated.
  • Ongoing assessment for signs of infection, blood clots, cardiovascular events, and malignancy at each review.
(6) (1)

Storage

Store at room temperature in the original packaging, away from moisture, and out of reach of children.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and the current New Zealand Medsafe data sheet for Rinvoq; verify against the current full label before prescribing.

United States / United Kingdom / European Union / Canada / Australia / New Zealand

Indication: Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (AS/nr-axSpA), giant cell arteritis

Dose summary: 15 mg once daily (giant cell arteritis with a corticosteroid taper).

Renal context: Individualised; no universal fixed adjustment identified across the sources reviewed, but caution and monitoring are advised in renal impairment. (2) (6)

United States / United Kingdom / European Union / Canada / Australia / New Zealand

Indication: Atopic dermatitis

Dose summary: 15 mg once daily, may increase to 30 mg once daily depending on response.

Renal context: Not specifically detailed in the sources reviewed; individualise per clinician judgement. (1)

United States / United Kingdom / European Union / Canada / Australia / New Zealand

Indication: Ulcerative colitis / Crohn's disease

Dose summary: 45 mg once daily induction (8 weeks UC / 12 weeks CD), then 15-30 mg once daily maintenance.

Renal context: Not specifically detailed in the sources reviewed; individualise per clinician judgement. (1) (2)

Mechanism of action

Hepatic guidance

Contraindicated in severe hepatic impairment; used with caution and monitoring in moderate impairment.

Overdose note

No specific antidote; manage with supportive care and monitoring; contact poison control for guidance. (1) (2)

Frequently asked questions

Is Rinvoq (upadacitinib) available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes. It is confirmed authorised in all six of these markets via direct regulator sources, across a range of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, and giant cell arteritis. (1) (2) (3) (4) (5) (6)

Why does upadacitinib have a boxed warning?

Upadacitinib belongs to a class of medicines called JAK inhibitors, all of which carry the same class-wide warning for five real risks: serious infections, an increased risk of death in certain patient groups, cancer, major cardiovascular events (like heart attack and stroke), and blood clots. Much of the comparative safety data behind this warning came from a large postmarketing study of a different JAK inhibitor medicine, and was applied to the whole class as a precaution; upadacitinib's own studies also showed higher rates of certain risks (like skin cancer and infections) with its higher 30 mg dose compared with 15 mg. (1) (6)

Can I take Rinvoq if I am pregnant?

No. Upadacitinib is contraindicated in pregnancy because of a real risk of fetal harm shown in animal studies. Tell your clinician immediately if you become pregnant or are planning a pregnancy. (2) (1)

What is the mechanism of action of upadacitinib?

Upadacitinib is a reversible, selective inhibitor of Janus kinase 1 (JAK1), reducing the signalling of multiple pro-inflammatory cytokines involved in the pathophysiology of the approved inflammatory and autoimmune conditions. (1) (2)

What is the generic name of Upadacitinib?

The generic name is upadacitinib. (1) (2) (6)

What class of drug is upadacitinib?

Upadacitinib is classed as: Janus kinase (JAK) inhibitor. (1) (2) (6)

References

  1. RINVOQ (upadacitinib) extended-release tablets / RINVOQ LQ (upadacitinib) oral solution -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, AbbVie Inc. · United States · accessed 2026-07-30 · source 1
  2. RINVOQ 15 mg and 30 mg prolonged-release tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- AbbVie Ltd · United Kingdom · accessed 2026-07-30 · source 2
  3. Rinvoq, INN-upadacitinib -- EPAREuropean Medicines Agency (EMA), EPAR · European Union · accessed 2026-07-30 · source 3
  4. RINVOQ (upadacitinib) -- Product MonographHealth Canada Drug Product Database / AbbVie Canada · Canada · accessed 2026-07-30 · source 4
  5. RINVOQ upadacitinib 15 mg and 45 mg modified release tablet -- ARTG entries 312687 / 375857, and AusPARTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-30 · source 5
  6. RINVOQ New Zealand Data Sheet (DS v21, CCDS v24, dated 2026-03-09)Medsafe (New Zealand regulator) -- official New Zealand Data Sheet · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient upadacitinib names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Rinvoq15 mg, 1 mg/mL, 30 mg, 45 mg · abbvie inc.

United Kingdom

  • Rinvoq (2)MHRA licensed emc smpc confirmed · 15 mg, 30 mg · AbbVie Ltd

Canada

  • Rinvoq (4)Health Canada approved confirmed · 15 mg · AbbVie Corporation

Australia

  • Rinvoq (5)TGA ARTG registered 2020-01-17 and 2022-09-20 confirmed PBS listed · 15 mg, 45 mg · AbbVie Pty Ltd

New Zealand

  • Rinvoq (6)Medsafe registered confirmed data sheet 2026-03-09 Pharmac special authority funded · 15 mg, 30 mg, 45 mg · AbbVie Limited
View brands in additional countries.

European Union

Rinvoq (3)