Tofacitinib
Tofacitinib is a Janus kinase (JAK) inhibitor used to treat inflammatory and autoimmune conditions by targeting intracellular enzymes involved in immune cell signaling. It is prescribed primarily for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and juvenile idiopathic arthritis when other treatments have not been effective.
Tofacitinib is an immunosuppressant JAK inhibitor used to treat inflammatory conditions like rheumatoid arthritis and ulcerative colitis.
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
- L04AF01
- RxNorm
- 1357536
- Generic
- Tofacitinib
- Class
- atc-l04
- Brands
- Xeljanz
- 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
- 5mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- weight-based (5mg twice daily for ≥40kg)
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 5mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second and third trimesteravoid
discontinue treatment if pregnancy occurs
fetal growth monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
do not breastfeed during treatment and for at least 18 hours after last dose
none
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65 years and olderno dose adjustment required
use with caution due to increased infection risk
regular monitoring for infections
Use with caution and monitor for adverse effects.
pediatric_age
under 18 yearsnot recommended
not approved for use in pediatric patients for rheumatoid arthritis; limited data for juvenile idiopathic arthritis
none
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
severe creatinine clearance less than 30no specific dose adjustment but use with caution
use with caution in patients with severe renal impairment
monitor renal function regularly
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate hepatic impairmentreduce dose to 5mg once daily
reduce dose to 5mg once daily in patients with moderate hepatic impairment
monitor liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
severe hepatic impairmentnot recommended
not recommended in severe hepatic impairment
liver function monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
Drug class
Janus kinase inhibitor classification
FDA approval year
Initial FDA approval date for Xeljanz
Common uses
Approved therapeutic indications
Mechanism of action
Pharmacological mechanism of action
Tofacitinib is indicated for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular juvenile idiopathic arthritis in patients who have not responded adequately to conventional therapies.
As a JAK inhibitor, tofacitinib blocks Janus kinase enzymes that transmit signals from cytokine and growth factor receptors on cell surfaces. This interruption affects immune cell function and hematopoiesis, reducing the inflammatory response that drives autoimmune conditions.
Tofacitinib carries a boxed warning for serious infections, malignancy, and cardiovascular events. It may increase the risk of blood clots and should not be used in combination with biologic DMARDs or potent immunosuppressants. Patients should be monitored for signs of infection during treatment.
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