Upadacitinib is an oral selective Janus kinase (JAK) inhibitor that was developed by AbbVie to manage autoimmune and inflammatory conditions. Research into JAK inhibition began in the early 2000s, with Upadacitinib being designed as a more selective inhibitor compared to earlier JAK drugs, aiming to improve efficacy while reducing side effects.

The U.S. FDA first approved Upadacitinib in August 2019 for the treatment of moderate to severe rheumatoid arthritis (RA) in adults who had an inadequate response or intolerance to methotrexate. Since then, it has received additional approvals for psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and ulcerative colitis in various regions, including the U.S., Europe, and Asia.

Upadacitinib is used in the treatment of:

• Rheumatoid Arthritis (RA) – moderate to severe, in patients unresponsive to methotrexate.

• Psoriatic Arthritis (PsA) – for patients with inadequate response to conventional therapy.

• Atopic Dermatitis (AD) – moderate to severe cases where systemic therapy is appropriate.

• Ankylosing Spondylitis (AS) – active cases not responding to conventional treatments.

• Ulcerative Colitis (UC) – moderately to severely active disease after inadequate response to other medicines.

Upadacitinib blocks Janus kinase (JAK) enzymes, which are involved in transmitting inflammatory signals from cytokines and growth factors inside immune cells. By selectively inhibiting JAK1, Upadacitinib reduces immune system overactivity and decreases inflammation. This leads to improvements in pain, swelling, stiffness, and other chronic inflammatory symptoms.

Unlike injectable biologics, Upadacitinib is taken orally, providing a convenient long-term therapy option.

• Form: Oral tablets.

• Typical Dose: Once daily, with or without food.

• Tablets should be swallowed whole; do not crush, split, or chew.

• The dose may vary depending on the condition being treated.

• Treatment should be initiated and monitored by a specialist physician.

Common (mild to moderate):

• Upper respiratory tract infections

• Nausea, headache, or stomach pain

• Acne

• Fatigue or dizziness

• Cough or fever.

Serious (seek urgent medical attention):

• Severe infections (TB, shingles, pneumonia)

• Blood clots in the veins or lungs

• Chest pain or shortness of breath

• Severe stomach pain or black stools (possible bleeding)

• Allergic reactions (rash, swelling, breathing difficulty)

• Liver problems (yellow eyes/skin, dark urine).

• Infections: May increase risk of tuberculosis, shingles, or serious bacterial/viral infections.

• Blood Clots & Heart Risks: Higher risk in patients with cardiovascular disease.

• Cancer Risk: Rare, but prolonged immunosuppression may slightly raise cancer risk.

• Liver and Kidney: Requires monitoring of liver/kidney function during treatment.

• Pregnancy/Breastfeeding: Not recommended; may harm the baby.

• Contraception: Use effective birth control during and after treatment.

• Vaccinations: Avoid live vaccines while taking Upadacitinib.

• Regular Monitoring: Blood counts, liver enzymes, kidney function, and cholesterol levels should be checked regularly.

• Medical History: Inform your doctor about heart disease, blood clots, liver problems, or chronic infections.

• Do not start treatment if you have an active infection.

• Your doctor may test for tuberculosis and hepatitis before starting therapy.

• Routine blood tests (liver, kidney, cholesterol, blood counts) are required during treatment.

• Inform your doctor if you are scheduled for vaccinations, as live vaccines are not recommended while on Upadacitinib.

• Always take the medicine as directed; do not stop suddenly without consulting your physician.

1. A Rubbert-Roth et al., “Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis,” The New England Journal of Medicine, [October 2020], demonstrating upadacitinib’s remission rates compared to abatacept in RA patients https://www.nejm.org/doi/full/10.1056/NEJMoa2008250?

3. R Sanmartí et al., “Upadacitinib for Patients with Rheumatoid Arthritis,” summarizing the phase II BALANCE I & II trials (dose-ranging) and the phase III SELECT trial program for RA regulatory approval https://pmc.ncbi.nlm.nih.gov/articles/PMC10002765/?
   

4. GR Burmester et al., “Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease,” Advances in Therapy, [2025], analysing long-term safety across multiple disease indications https://pubmed.ncbi.nlm.nih.gov/36754548/

5. C Zhang et al., “Safety profile and dose-dependent adverse events of upadacitinib: a meta-analysis,” Frontiers in Pharmacology, [2025], highlighting dose-related risks such as hepatic disorders, neutropenia, and acne https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1598972/full

The drug information on this page is different from medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you can receive this treatment.