Upadacitinib
Upadacitinib is a Janus kinase (JAK) inhibitor used to treat inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, ulcerative colitis, and Crohn's disease. It works by blocking intracellular enzymes that transmit inflammatory signals from cytokine receptors, thereby reducing immune system activity and inflammation.
Upadacitinib is an immunosuppressant JAK inhibitor used to treat various inflammatory and autoimmune conditions by blocking inflammatory signaling pathways inside immune cells.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L04AF03
- RxNorm
- 2196092
- Generic
- Upadacitinib
- Class
- atc-l04
- Brands
- Rinvoq
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- tablet, solution
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 15mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 30mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 15mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks. Discontinue at least 5 days before planned pregnancy.
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second and third trimesteravoid
continue to avoid use throughout pregnancy. JAK inhibitors may affect immune system development.
comprehensive fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
not recommendeddiscontinue breastfeeding or discontinue drug
do not breastfeed during treatment with upadacitinib and for at least 6 days after last dose
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
adolescents 12 to 17 yearsno adjustment for patients >=12 years
approved for patients 12 years and older for certain indications including psoriatic arthritis and ankylosing spondylitis. Monitor for growth and development.
regular monitoring of growth parameters, CBC, and lipid panels
Use with caution and monitor for adverse effects.
geriatric
65 years and olderno specific adjustment required
use with caution. Increased risk of infections, malignancies, and major adverse cardiovascular events in elderly patients. Start at lower end of dosing range.
regular monitoring for infections, lipid panels, and cardiovascular risk factors
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderateno dose adjustment needed
no dose adjustment needed for mild to moderate renal impairment (CrCl 30-89 mL/min)
routine renal function monitoring
renal_impairment
severeuse with caution, not recommended for CrCl <30 mL/min
use with caution in patients with severe renal impairment. Not recommended for end-stage renal disease.
more frequent renal function monitoring
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderateno dose adjustment needed
no dose adjustment needed for mild to moderate hepatic impairment (Child-Pugh A and B)
routine liver function test monitoring
hepatic_impairment
severeuse with caution, limited data
use with caution in patients with severe hepatic impairment (Child-Pugh C). Consider risks versus benefits.
regular liver function monitoring
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Upadacitinib is a selective JAK1 inhibitor
FDA approval year
Rinvoq FDA approval date
Mechanism of action
Molecular mechanism of action
Common uses
Approved therapeutic indications
Treats moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, ulcerative colitis, and Crohn's disease in adults when other treatments have not been effective or are not tolerated.
Upadacitinib selectively inhibits JAK1 and JAK3 enzymes, blocking intracellular signaling pathways activated by cytokines and growth factors. This reduces the activation and proliferation of immune cells involved in inflammation, decreasing inflammatory responses throughout the body.
May increase risk of serious infections, malignancy, and cardiovascular events. Patients should be monitored for signs of infection and blood abnormalities. Live vaccines should be avoided during treatment. Common side effects include upper respiratory tract infections, acne, and headache. Not recommended during pregnancy.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy