RINVOQ (Upadacitinib)

Selective JAK1 Inhibitor for Autoimmune and Inflammatory Conditions

Rx – Prescription Only JAK Inhibitor
Active Ingredient
Upadacitinib
Available Forms
Extended-release tablets
Strengths
15 mg, 30 mg, 45 mg
Manufacturer
AbbVie
Medically reviewed | Last reviewed: | Evidence level: 1A
RINVOQ (upadacitinib) is a selective Janus kinase 1 (JAK1) inhibitor used to treat a range of autoimmune and inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, giant cell arteritis, atopic dermatitis, ulcerative colitis, and Crohn’s disease. By selectively blocking JAK1, RINVOQ reduces immune-mediated inflammation. It is taken once daily as an extended-release tablet.
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Quick Facts About RINVOQ

Active Ingredient
Upadacitinib
(as hemihydrate)
Drug Class
JAK1 Inhibitor
Janus Kinase Inhibitor
Administration
Oral
Once daily tablet
Common Uses
Autoimmune
RA, AD, UC, CD & more
Available Forms
ER Tablets
15 mg, 30 mg, 45 mg
Prescription Status
Rx Only
Prescription required

Key Takeaways About RINVOQ

  • Broad indication range: RINVOQ is approved for rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, giant cell arteritis, atopic dermatitis, ulcerative colitis, and Crohn’s disease
  • Selective JAK1 inhibition: Upadacitinib preferentially targets JAK1, which may offer a more favourable efficacy–safety profile compared to less selective JAK inhibitors
  • Infection risk: RINVOQ suppresses the immune system and increases the risk of serious infections including tuberculosis, herpes zoster (shingles), and opportunistic infections
  • Regular blood monitoring required: Blood tests are needed before and during treatment to check blood cell counts, liver function, and cholesterol levels
  • Contraindicated in pregnancy: RINVOQ must not be used during pregnancy, and effective contraception is required for at least 4 weeks after stopping treatment

What Is RINVOQ and What Is It Used For?

RINVOQ (upadacitinib) is a selective Janus kinase 1 (JAK1) inhibitor that works by reducing the activity of the JAK1 enzyme in the body, thereby decreasing inflammation in multiple autoimmune and inflammatory diseases. It is used to treat rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, giant cell arteritis, atopic dermatitis, ulcerative colitis, and Crohn’s disease.

RINVOQ belongs to a class of medicines known as Janus kinase (JAK) inhibitors. The Janus kinases are a family of intracellular enzymes (JAK1, JAK2, JAK3, and TYK2) that transmit signals from cytokines and growth factors on the cell surface to the cell’s nucleus, activating gene expression that drives immune responses. Upadacitinib selectively inhibits JAK1, which is a key mediator of signalling for multiple pro-inflammatory cytokines involved in autoimmune diseases, including interleukin-6 (IL-6), interleukin-7 (IL-7), interleukin-15 (IL-15), and interferons.

By blocking JAK1-dependent signalling pathways, RINVOQ reduces the activation and proliferation of immune cells responsible for the chronic inflammation that characterises autoimmune conditions. This targeted mechanism allows RINVOQ to address the underlying inflammatory process rather than simply managing symptoms, making it an effective disease-modifying therapy across a range of indications.

Rheumatoid Arthritis

RINVOQ is used to treat adults with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to, or are intolerant of, one or more disease-modifying antirheumatic drugs (DMARDs), most commonly methotrexate. It can be used alone (monotherapy) or in combination with methotrexate. Clinical trials have demonstrated that RINVOQ significantly reduces joint pain, stiffness, and swelling, improves physical function, and slows the progression of structural joint damage. The European Alliance of Associations for Rheumatology (EULAR) includes JAK inhibitors as a treatment option for RA patients with inadequate response to conventional DMARDs.

Psoriatic Arthritis

In adults with active psoriatic arthritis (PsA), RINVOQ is indicated when previous DMARD therapy has not been sufficiently effective. Psoriatic arthritis causes joint inflammation alongside psoriasis skin lesions. RINVOQ has been shown to reduce joint symptoms, spinal pain and stiffness, psoriasis skin rash, and fatigue. It can also slow structural damage to bones and cartilage in affected joints, and can be used alone or with methotrexate.

Axial Spondyloarthritis

RINVOQ is approved for adults with active axial spondyloarthritis (axSpA), including both non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS, also known as radiographic axSpA). These conditions primarily cause inflammation and pain in the spine. RINVOQ reduces back pain, stiffness, and spinal inflammation, helping patients maintain mobility and carry out daily activities more easily.

Giant Cell Arteritis

RINVOQ is used to treat adults with giant cell arteritis (GCA), an inflammatory disease affecting the medium and large arteries, particularly those in the head, neck, and arms. Symptoms include headache, scalp tenderness, jaw pain, and fatigue. GCA is often treated with corticosteroids, which can cause significant side effects when used at high doses or for prolonged periods. By adding RINVOQ to treatment, corticosteroids may be used for shorter durations while maintaining disease control and reducing the risk of flares.

Atopic Dermatitis

RINVOQ is indicated for adults and adolescents aged 12 years and older (weighing at least 30 kg) with moderate to severe atopic dermatitis (eczema) where topical therapies have not provided adequate disease control. RINVOQ can be used with or without topical eczema medications. Clinical studies have shown that RINVOQ improves skin condition, reduces itching and flare-ups, and alleviates associated symptoms such as pain, anxiety, depression, and sleep disturbances.

Ulcerative Colitis

RINVOQ is approved for adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, or intolerance of, prior therapy. Ulcerative colitis is an inflammatory bowel disease affecting the colon. RINVOQ helps reduce symptoms such as bloody stools, abdominal pain, urgency, and frequent bowel movements, allowing patients to resume normal daily activities and reducing fatigue.

Crohn’s Disease

RINVOQ is indicated for adults with moderately to severely active Crohn’s disease who have had an inadequate response to, or intolerance of, previous treatment. Crohn’s disease is an inflammatory bowel disease that can affect any part of the gastrointestinal tract but most commonly the intestines. RINVOQ reduces urgency and frequency of bowel movements, abdominal pain, and intestinal mucosal inflammation, enabling patients to carry out their daily activities with less fatigue.

Good to know:

RINVOQ was first approved by the European Medicines Agency (EMA) in December 2019 for rheumatoid arthritis, and by the U.S. Food and Drug Administration (FDA) in August 2019. Since then, its approved indications have expanded considerably to include multiple autoimmune and inflammatory conditions, making it one of the most broadly indicated JAK inhibitors available.

What Should You Know Before Taking RINVOQ?

Before starting RINVOQ, your doctor will screen you for infections (including tuberculosis), check your blood counts and liver function, and review your vaccination history. RINVOQ is contraindicated in patients with serious active infections, active tuberculosis, severe liver impairment, and during pregnancy.

Contraindications

You should not take RINVOQ if any of the following apply to you:

  • Allergy to upadacitinib or any other ingredient in this medicine – symptoms may include skin rash, difficulty breathing, or swelling
  • Serious active infection such as pneumonia or a bacterial skin infection – RINVOQ could worsen the infection
  • Active tuberculosis (TB) – your doctor will test for TB before starting treatment
  • Severe liver disease – impaired liver function can increase drug levels and the risk of side effects
  • Pregnancy – RINVOQ can cause harm to the developing foetus and must not be used during pregnancy

Warnings and Precautions

Talk to your doctor or pharmacist before and during treatment with RINVOQ if any of the following apply:

  • Current or frequent infections: RINVOQ can reduce your body’s ability to fight infections and may worsen existing infections or increase the risk of new ones. Tell your doctor immediately if you develop fever, wounds, unusual tiredness, or dental problems
  • History of tuberculosis or TB exposure: Your doctor will test you for TB before starting RINVOQ and may repeat the test during treatment
  • History of herpes zoster (shingles): RINVOQ may trigger a recurrence of shingles. Inform your doctor if you develop a painful skin rash with blisters
  • Hepatitis B or C: Prior or current viral hepatitis requires careful assessment before starting treatment
  • Recent or planned vaccination: Live vaccines are not recommended during RINVOQ treatment because the immune suppression could allow vaccine viruses to cause infection
  • Cancer history or current smoking: Your doctor will assess whether RINVOQ is appropriate, as JAK inhibitors may be associated with increased malignancy risk in certain populations
  • Non-melanoma skin cancer: Cases have been observed in patients taking RINVOQ. Regular skin examinations are recommended. Report any new or changing skin lesions to your doctor
  • Heart disease: Your doctor will evaluate your cardiovascular risk factors before prescribing RINVOQ
  • Blood clot history (deep vein thrombosis or pulmonary embolism): Tell your doctor if you have risk factors for thrombosis, such as recent major surgery, use of hormonal contraceptives, or a personal or family history of clotting disorders. Seek immediate medical attention for sudden shortness of breath, chest pain, leg swelling, or leg pain
  • Vision changes: Seek immediate medical attention if you experience sudden blurred vision or partial or complete vision loss, as these may indicate blocked blood flow in the eyes
  • Kidney problems: Dose adjustments may be necessary for patients with renal impairment
  • Diverticulitis or gastrointestinal ulcers: Inform your doctor if you have unexplained abdominal pain or a history of diverticulitis, stomach or intestinal ulcers, or if you take NSAIDs
Seek immediate medical attention if you experience:
  • Skin rash (hives), difficulty breathing, or swelling of the lips, tongue, or throat – signs of a serious allergic reaction
  • Severe abdominal pain, especially if accompanied by fever, nausea, and vomiting – possible signs of gastrointestinal perforation

Blood Tests and Monitoring

You will have blood tests before starting RINVOQ and at regular intervals during treatment. These tests check for low red blood cells (anaemia), low white blood cells (neutropenia or lymphopenia), elevated cholesterol levels, and elevated liver enzymes. The results help your doctor ensure that RINVOQ treatment is not causing problems and allow early intervention if abnormalities are detected. The frequency of monitoring is determined by your doctor based on your individual risk profile.

Elderly Patients

The rate of infections is higher in patients aged 65 years and older. Elderly patients may also face increased risks of cardiovascular events, infections, and certain types of cancer. Your doctor will carefully evaluate whether RINVOQ is the right treatment for you if you are 65 years or older. For ulcerative colitis and Crohn’s disease, the recommended long-term maintenance dose in patients 65 years and older is 15 mg once daily.

Children and Adolescents

RINVOQ is not recommended for children under 12 years of age or adolescents weighing less than 30 kg with atopic dermatitis, as the medicine has not been studied in these patients. RINVOQ is not recommended for children and adolescents under 18 years of age with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, or Crohn’s disease, as it has not been studied in these age groups for these indications.

Pregnancy and Breastfeeding

RINVOQ must not be used during pregnancy. Animal studies have shown harmful effects on the developing foetus. If you are a woman of childbearing potential, you must use effective contraception during treatment and for at least 4 weeks after your last dose. If you become pregnant during this time, inform your doctor immediately.

RINVOQ should not be used during breastfeeding. It is unknown whether upadacitinib passes into breast milk. You and your doctor should decide together whether you should breastfeed or take RINVOQ – you should not do both. If your child begins menstruation while taking RINVOQ, the prescribing doctor should be informed.

Driving and Operating Machinery

RINVOQ may cause dizziness or a spinning sensation (vertigo). If you experience these symptoms, do not drive a car or operate machinery until the symptoms have resolved.

How Does RINVOQ Interact with Other Drugs?

RINVOQ can interact with several medications, particularly strong CYP3A4 inhibitors and inducers, other immunosuppressants, and certain antifungals and antibiotics. These interactions may increase side effects or reduce the effectiveness of RINVOQ. Always tell your doctor about all medicines you are taking.

Upadacitinib is primarily metabolised by the liver enzyme CYP3A4. Drugs that inhibit this enzyme can increase upadacitinib blood levels, potentially raising the risk of side effects. Conversely, drugs that induce CYP3A4 can decrease upadacitinib levels and reduce its efficacy. Additionally, combining RINVOQ with other immunosuppressive agents may excessively suppress the immune system, increasing infection risk.

Major Interactions

Major Drug Interactions with RINVOQ
Drug Category Effect Recommendation
Ketoconazole Antifungal / Cushing’s treatment Strong CYP3A4 inhibitor that significantly increases upadacitinib blood levels Use with caution; dose adjustment may be required
Itraconazole / Posaconazole / Voriconazole Antifungals Strong/moderate CYP3A4 inhibitors that increase upadacitinib exposure Monitor for increased side effects; dose reduction may be needed
Clarithromycin Macrolide antibiotic CYP3A4 inhibitor that increases upadacitinib blood levels Monitor closely; consider alternative antibiotic if possible
Azathioprine / 6-Mercaptopurine Immunosuppressants Additive immunosuppression with increased infection risk Combination is not recommended
Cyclosporine / Tacrolimus Immunosuppressants Excessive immune suppression and increased toxicity risk Combination is not recommended

Moderate Interactions

Moderate Drug Interactions with RINVOQ
Drug Category Effect Recommendation
Rifampicin TB treatment Strong CYP3A4 inducer that significantly reduces upadacitinib effectiveness Avoid concurrent use if possible; efficacy may be compromised
Phenytoin Anticonvulsant CYP3A4 inducer that may decrease upadacitinib blood levels Monitor treatment response; dose adjustment may be needed
NSAIDs (e.g. ibuprofen, naproxen) Anti-inflammatory / analgesic May increase risk of gastrointestinal perforation or diverticulitis Use with caution, especially with concurrent corticosteroids or opioids
Corticosteroids Anti-inflammatory Additive immunosuppressive effects and increased gastrointestinal risk Taper corticosteroids when clinically appropriate; use lowest effective dose
Antidiabetic medicines Diabetes treatment Upadacitinib may alter blood glucose control Monitor blood sugar; antidiabetic dose adjustment may be needed
Grapefruit / Grapefruit juice Food CYP3A4 inhibitor that increases upadacitinib levels Avoid grapefruit and grapefruit juice during treatment

If you are taking any of the above medications, or if you are unsure about potential interactions, talk to your doctor or pharmacist before taking RINVOQ. RINVOQ is often prescribed alongside methotrexate for rheumatoid arthritis and psoriatic arthritis, and this combination has been extensively studied and is generally well tolerated.

What Is the Correct Dosage of RINVOQ?

The dosage of RINVOQ depends on the condition being treated. For rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and giant cell arteritis, the recommended dose is 15 mg once daily. For atopic dermatitis and inflammatory bowel diseases, higher induction doses may be used. Swallow the tablet whole with water – do not split, crush, or chew.

Always take RINVOQ exactly as your doctor has prescribed. Do not change your dose without consulting your doctor. Take the extended-release tablet whole with water – do not split, crush, chew, or break the tablet, as this can affect the amount of medicine released in your body. RINVOQ can be taken with or without food at the same time each day for consistent effect.

Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, and Giant Cell Arteritis

Standard Adult Dose

Recommended dose: 15 mg once daily

This dose is used for all four of these conditions. RINVOQ can be taken alone or in combination with methotrexate for rheumatoid arthritis and psoriatic arthritis.

Atopic Dermatitis

Adults (18–64 years)

Recommended dose: 15 mg or 30 mg once daily, as prescribed by your doctor

Your doctor may adjust the dose based on your response to treatment.

Adolescents (12–17 years, ≥30 kg)

Recommended dose: 15 mg once daily

Your doctor may increase the dose to 30 mg once daily depending on treatment response.

Elderly (≥65 years)

Recommended dose: 15 mg once daily

Ulcerative Colitis

Induction Phase

Dose: 45 mg once daily for 8 weeks

Your doctor may extend the 45 mg induction dose for an additional 8 weeks (total 16 weeks) if needed.

Maintenance Phase

Dose: 15 mg or 30 mg once daily (long-term)

Elderly patients (≥65 years): 15 mg once daily is recommended for maintenance.

Crohn’s Disease

Induction Phase

Dose: 45 mg once daily for 12 weeks

Maintenance Phase

Dose: 15 mg or 30 mg once daily (long-term)

Elderly patients (≥65 years): 15 mg once daily is recommended for maintenance. Your doctor may adjust the dose for kidney problems or if you take certain other medications.

Missed Dose

If you forget a dose, take it as soon as you remember on the same day. If you have missed a dose for an entire day, skip it and take your normal dose the following day. Do not take a double dose to compensate for a missed tablet.

Overdose

Overdose Warning:

If you take more RINVOQ than prescribed, contact your doctor immediately. You may experience some of the side effects described in the side effects section. Seek immediate medical attention if you suspect an overdose. Contact your local emergency services or poison control centre without delay.

Stopping RINVOQ

Do not stop taking RINVOQ unless your doctor tells you to. Stopping treatment without medical supervision may lead to a flare-up of your underlying condition. If you have any questions about your treatment duration, speak with your doctor or pharmacist.

What Are the Side Effects of RINVOQ?

The most common side effects of RINVOQ are upper respiratory infections (throat and nose) and acne. Serious side effects include herpes zoster (shingles), pneumonia, blood stream infections, and allergic reactions. Report any new or worsening symptoms to your doctor promptly.

Like all medicines, RINVOQ can cause side effects, although not everybody gets them. The risk of certain side effects may vary depending on the condition being treated, the dose used, and individual risk factors such as age and other medical conditions.

Seek immediate medical attention if you experience:
  • Chest tightness, wheezing, swelling of the lips, tongue, or throat, or hives – signs of a serious allergic reaction
  • Painful skin rash with blisters – possible shingles (herpes zoster)
  • Shortness of breath, fever, and productive cough – possible pneumonia
  • Severe abdominal pain with fever, nausea, and vomiting – possible gastrointestinal perforation
  • Sudden shortness of breath, chest pain, leg swelling, or leg pain – possible blood clot
  • Sudden blurred vision or vision loss – possible blocked blood flow in the eyes

Very Common

May affect more than 1 in 10 people

  • Upper respiratory tract infections (throat and nose infections)
  • Acne

Common

May affect up to 1 in 10 people

  • Non-melanoma skin cancer
  • Cough
  • Fever
  • Cold sores (herpes simplex)
  • Nausea
  • Elevated creatine kinase (shown in blood tests)
  • Low white blood cell count (shown in blood tests)
  • Elevated cholesterol levels (shown in blood tests)
  • Elevated liver enzymes (shown in blood tests)
  • Weight gain
  • Folliculitis (inflammation of hair follicles)
  • Influenza
  • Anaemia (low red blood cells)
  • Abdominal pain
  • Fatigue
  • Headache
  • Hives (urticaria)
  • Urinary tract infection
  • Skin rash
  • Dizziness or vertigo (spinning sensation)
  • Bronchitis (lung infection)
  • Peripheral oedema (swelling of feet and hands)
  • Herpes zoster (shingles)
  • Pneumonia

Uncommon

May affect up to 1 in 100 people

  • Oral thrush (white patches in the mouth)
  • Elevated triglycerides (shown in blood tests)
  • Diverticulitis (inflammation of small pouches in the intestinal lining)
  • Gastrointestinal perforation (hole in the bowel wall)
  • Blood stream infection (sepsis)
  • Serious allergic reaction (anaphylaxis)

Additional Side Effects in Adolescents with Atopic Dermatitis

Common in adolescents

  • Warts (skin papilloma)

If you experience any side effects not listed here, or if any side effect becomes severe or persistent, contact your doctor or pharmacist. Reporting suspected side effects after a medicine has been authorised is important, as it allows ongoing monitoring of the medicine’s benefit–risk balance.

How Should You Store RINVOQ?

Store RINVOQ at room temperature in its original blister packaging to protect from moisture. Keep the medicine out of the sight and reach of children. Do not use after the expiry date printed on the packaging.

No special temperature requirements apply to RINVOQ tablets. However, the medicine is sensitive to moisture and should be kept in its original blister pack until you are ready to take a tablet. Check the expiry date (marked “EXP” on the blister and carton) before each dose. The expiry date refers to the last day of the stated month.

Do not dispose of RINVOQ tablets by flushing them down the toilet or placing them in household waste. Return any unused or expired medication to your pharmacy for safe disposal. This helps protect the environment from pharmaceutical contamination.

What Does RINVOQ Contain?

RINVOQ contains the active substance upadacitinib (as upadacitinib hemihydrate). The tablets are available in 15 mg, 30 mg, and 45 mg strengths, each with a distinctive colour and imprint for easy identification.

Active Ingredient

The active substance is upadacitinib. Each 15 mg tablet contains upadacitinib hemihydrate equivalent to 15 mg upadacitinib. Each 30 mg tablet contains upadacitinib hemihydrate equivalent to 30 mg upadacitinib. Each 45 mg tablet contains upadacitinib hemihydrate equivalent to 45 mg upadacitinib.

Inactive Ingredients (Excipients)

Tablet core: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, colloidal anhydrous silica, magnesium stearate.

Film coating (15 mg): poly(vinyl alcohol), macrogol, talc, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172).

Film coating (30 mg): poly(vinyl alcohol), macrogol, talc, titanium dioxide (E171), red iron oxide (E172).

Film coating (45 mg): poly(vinyl alcohol), macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Tablet Appearance and Packaging

15 mg tablets: Purple, oval, biconvex tablets imprinted with “a15” on one side. Available in blister packs of 28 or 98 tablets, or jars containing 30 tablets.

30 mg tablets: Red, oval, biconvex tablets imprinted with “a30” on one side. Available in blister packs of 28 or 98 tablets, or jars containing 30 tablets.

45 mg tablets: Yellow to mottled yellow, oval, biconvex tablets imprinted with “a45” on one side. Available in blister packs of 28 tablets, or jars containing 28 tablets.

Each calendar blister contains 7 tablets. Not all pack sizes may be marketed in your country.

How Does RINVOQ Work in the Body?

RINVOQ works by selectively inhibiting Janus kinase 1 (JAK1), an intracellular enzyme that transmits signals from pro-inflammatory cytokines. By blocking JAK1, RINVOQ reduces the activation of immune cells that drive chronic inflammation in autoimmune diseases. Its selectivity for JAK1 over other JAK family members distinguishes it from earlier, less selective JAK inhibitors.

The Janus kinase (JAK) family consists of four enzymes: JAK1, JAK2, JAK3, and TYK2. These enzymes work in pairs to transmit signals from cytokine receptors on the cell surface to the cell nucleus via the JAK-STAT (Signal Transducer and Activator of Transcription) signalling pathway. Different cytokines use different JAK combinations, which means that selectively targeting one JAK can influence specific inflammatory pathways while potentially sparing others.

Upadacitinib was engineered to be selective for JAK1, which is a central mediator of signalling for many of the cytokines most relevant to autoimmune inflammation, including interleukin-6 (IL-6), interleukin-7 (IL-7), interleukin-15 (IL-15), interleukin-21 (IL-21), and type I and type II interferons. By preferentially inhibiting JAK1 over JAK2 (which is important for haematopoiesis and erythropoietin signalling), JAK3 (critical for lymphocyte development), and TYK2, upadacitinib aims to maximise anti-inflammatory efficacy while minimising off-target effects.

In practical terms, blocking JAK1-dependent cytokine signalling results in reduced activation and proliferation of T cells, B cells, and natural killer cells, decreased production of inflammatory mediators, and attenuation of the inflammatory cascade that drives joint destruction in arthritis, skin inflammation in eczema, intestinal mucosal damage in inflammatory bowel disease, and vascular inflammation in giant cell arteritis.

Pharmacokinetic Profile

After oral administration, upadacitinib from the extended-release tablet formulation is absorbed with peak plasma concentrations reached approximately 2–4 hours after dosing. The oral bioavailability is approximately 76%. Absorption is not significantly affected by food, so the tablet can be taken with or without meals. Upadacitinib is approximately 52% bound to plasma proteins.

Upadacitinib is primarily metabolised by CYP3A4, with minor contributions from CYP2D6. The terminal elimination half-life is approximately 9–14 hours, supporting once-daily dosing. The extended-release formulation is specifically designed to provide sustained drug levels throughout the 24-hour dosing interval. Approximately 53% of the administered dose is excreted unchanged in urine, with 24% eliminated in faeces.

Frequently Asked Questions About RINVOQ

RINVOQ (upadacitinib) is a JAK inhibitor used to treat several autoimmune and inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis), giant cell arteritis, atopic dermatitis, ulcerative colitis, and Crohn’s disease. It works by reducing the activity of the Janus kinase 1 enzyme, which helps decrease inflammation in the body.

The most common side effects are upper respiratory tract infections (throat and nose infections) and acne, occurring in more than 1 in 10 people. Other common side effects include shingles (herpes zoster), cough, nausea, fever, elevated liver enzymes, elevated cholesterol, headache, fatigue, and urinary tract infections. Most side effects are manageable with regular medical monitoring.

No, RINVOQ must not be used during pregnancy. Animal studies have shown harmful effects on the developing foetus. Women of childbearing potential must use effective contraception during treatment and for at least 4 weeks after the last dose. If you become pregnant while taking RINVOQ, stop taking the medicine and inform your doctor immediately. RINVOQ should also not be used while breastfeeding.

RINVOQ (upadacitinib) is a selective JAK1 inhibitor, meaning it preferentially targets JAK1 over other JAK family members (JAK2, JAK3, TYK2). This selectivity may offer advantages in terms of the balance between efficacy and safety compared to less selective JAK inhibitors such as tofacitinib (which inhibits JAK1 and JAK3) or baricitinib (which inhibits JAK1 and JAK2). RINVOQ is also approved for one of the broadest ranges of indications among JAK inhibitors.

Your doctor will perform blood tests before starting RINVOQ and at regular intervals during treatment. These include complete blood counts (checking for anaemia, neutropenia, or lymphopenia), liver function tests (checking for elevated liver enzymes), and lipid panels (checking cholesterol and triglyceride levels). You will also be screened for tuberculosis before starting treatment. The frequency of blood monitoring depends on your individual risk factors.

Live vaccines are not recommended while taking RINVOQ because the medicine suppresses the immune system, which could allow a live vaccine virus to cause infection. Inactivated (non-live) vaccines can generally be given during treatment. It is recommended to ensure all vaccinations, including the shingles vaccine, are up to date before starting RINVOQ therapy. Consult your doctor about your vaccination schedule before beginning treatment.

References

This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomised controlled trials.

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  2. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care & Research. 2021;73(7):924–939. doi:10.1002/acr.24596
  3. European Medicines Agency (EMA). RINVOQ (upadacitinib) – Summary of Product Characteristics. EMA product information database. Accessed January 2026.
  4. U.S. Food and Drug Administration (FDA). RINVOQ (upadacitinib) – Prescribing Information. Accessed January 2026.
  5. National Institute for Health and Care Excellence (NICE). Upadacitinib for treating moderate to severe rheumatoid arthritis. Technology appraisal guidance [TA665]. 2020.
  6. Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2). The Lancet. 2021;397(10290):2151–2168. doi:10.1016/S0140-6736(21)00588-2
  7. Danese S, Vermeire S, Zhou W, et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis (U-ACHIEVE). The Lancet. 2022;399(10341):2113–2128. doi:10.1016/S0140-6736(22)00581-5
  8. British National Formulary (BNF). Upadacitinib. NICE BNF monograph. Accessed January 2026.
  9. World Health Organization (WHO). WHO Model List of Essential Medicines. Geneva: WHO; 2023.

Editorial Team

This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in rheumatology, dermatology, gastroenterology, and clinical pharmacology.

Medical Writers

Board-certified physicians specialising in rheumatology, autoimmune diseases, and clinical pharmacology with documented academic and clinical experience.

Medical Reviewers

Independent review board ensuring clinical accuracy, adherence to international guidelines (EULAR, ACR, NICE, WHO), and evidence level 1A standards.

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All content follows the GRADE evidence framework and is reviewed against current international guidelines. We have no commercial funding or pharmaceutical sponsorship. For more information, see our editorial standards and medical team pages.