Tofacitinib: uses, dosing, side effects & brands
Tofacitinib is a janus kinase inhibitor sold in the U.S. under 2 brand and generic names, for rheumatoid arthritis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Janus Kinase Inhibitor
- Treats (across its forms)
- Rheumatoid Arthritis
- Available as
- Solution · Tablet · Tablet, extended release
- Sold as
- 2 products — Xeljanz and Tofacitinib Citrate
- Prescription?
- Prescription only
- Generic available?
- Yes
- Boxed warning
- Boxed warning
How Xeljanz is dosed
From the FDA label for Xeljanz (application NDA213082). Other tofacitinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended Evaluations and Immunization Prior to Treatment Initiation • Prior to initiating XELJANZ/XELJANZ XR, consider performing an active and latent TB evaluation, viral hepatitis screening, a complete blood count, and updating immunizations. Avoid XELJANZ or XELJANZ XR initiation if absolute lymphocyte count <500 cells/mm 3 , an absolute neutrophil count (ANC) <1000 cells/mm 3 or hemoglobin <9 g/dL. ( 2.1 ) Important Administration Instructions • XELJANZ XR (extended-release tablets) is not substitutable with XELJANZ (tablets and oral solution). ( 2.2 ) • Switching between XELJANZ and XELJANZ XR should be made by the healthcare provider. ( 2.2 ) Recommended Dosage Adult Patients with RA, PsA or AS • XELJANZ tablets 5 mg twice daily or XELJANZ XR (extended-release tablets) 11 mg once daily. ( 2.3 ) Pediatric Patients 2 Years of Age and Older with PsA or pcJIA Who Weigh At Least 10 kg • XELJANZ (tablets or oral solution) 5 mg twice daily for those ≥40 kg or weight-based equivalent twice daily for those <40 kg. ( 2.4 ) Adult Patients with UC • Induction: XELJANZ tablets 10 mg twice daily or XELJANZ XR 22 mg once daily for 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed, continue XELJANZ tablets 10 mg twice daily or XELJANZ XR 22 mg once daily for a maximum of 16 weeks. Discontinue XELJANZ tablets 10 mg twice…
Everything below is the FDA label for Xeljanz (solution, tablet). Tofacitinib is also sold as tablet, extended release, and those are different medicines to take — follow the label for the one you were prescribed.
Xeljanz side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections [see Warnings and Precautions (5.1) ] • Increased Risk of Mortality [see Warnings and Precautions (5.2) ] • Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions (5.3) ] • Major Adverse Cardiovascular Events [see Warnings and Precautions (5.4) ] • Thrombosis [see Warnings and Precautions (5.5) ] • Gastrointestinal Perforations [see Warnings and Precautions (5.6) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] • Hypoglycemia in Patients with Diabetes [see Warnings and Precautions (5.8) ] • Laboratory Abnormalities [see Warnings and Precautions (5.9) ] Most common adverse reactions are: • RA, PsA, and AS : Reported in ≥2% of adult patients treated with XELJANZ tablets monotherapy or in combination with DMARDs: upper respiratory tract infection (URI), nasopharyngitis, diarrhea, and headache. ( 6.1 ) • PcJIA : Consistent with common adverse reactions reported in adult patients with RA. ( 6.1 ) • UC : Reported in ≥ 5% of adult patients treated with either XELJANZ tablets and ≥1% greater than reported in patients treated with placebo: nasopharyngitis, elevated cholesterol levels, headache, URI, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact…
Who shouldn’t take Xeljanz
None. None. ( 4 )
Xeljanz drug interactions
Table 7 includes drugs with clinically significant drug interactions when concomitantly used with XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) and instructions for preventing or managing them. Table 7: Clinically Significant Interactions Affecting XELJANZ/XELJANZ XR When Concomitantly Used with Other Drugs Strong CYP3A4 Inhibitors (e.g., ketoconazole) Clinical Impact Increased exposure to tofacitinib Intervention Dosage modification of XELJANZ/XELJANZ XR is recommended [see Dosage and Administration (2) , Clinical Pharmacology, Figure 3 (12.3) ] Moderate CYP3A4 Inhibitors Concomitantly Used with Strong CYP2C19 Inhibitors (e.g., fluconazole) Clinical Impact Increased exposure to tofacitinib Intervention Dosage modification of XELJANZ/XELJANZ XR is recommended [see Dosage and Administration (2) , Clinical Pharmacology, Figure 3 (12.3) ] Strong CYP3A4 Inducers (e.g., rifampin) Clinical Impact Decreased exposure to tofacitinib and may result in loss of or reduced clinical response Intervention Concomitant use with XELJANZ/XELJANZ XR is not recommended [see Clinical Pharmacology, Figure 3 (12.3) ] Immunosuppressive Drugs (e.g., azathioprine, tacrolimus, cyclosporine) Clinical Impact Risk of added immunosuppression; concomitant use of XELJANZ/XELJANZ XR with biologic DMARDs or potent immunosuppressants has not been studied in patients with RA, PsA, AS, UC, or pcJIA. Intervention Concomitant use with XELJANZ/XELJANZ XR is not recommended [see Indications and Usage (1) , Clinical Pharmacology, Figure 3 (12.3) ] See FPI for clinically significant drug interactions. ( 2 , 7 )
Every tofacitinib product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 64/100 | Prescription | Solution | No data | — | View → | |
| 2 | Not yet rated | Prescription | Tablet | No data | — | View → |
What tofacitinib pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| T5 | 5 mg | white | round | — |
| T10 | 10 mg | blue | round | — |
| T1 | 11 mg | pink | oval | — |
Can you crush or split tofacitinib?
At least one tofacitinibproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each tofacitinib label says about crushing, splitting and chewingHow long tofacitinib keeps
The date on a sealed pack is not the only one: some tofacitinib labels start a second clock once the product is opened or mixed, as short as 60 days.
Does tofacitinib expire? The in-use limits and storage rules from its labelsTofacitinib and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for tofacitinib: levels in milk, effects in breastfed infants, and the drugs it would consider insteadData from 3 mothers indicate that the amount in milk is low, and no adverse effects were seen in infants who were exclusively breastfed during maternal tofacitinib use. Until more data become available, tofacitinib should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Expert opinion considers breastfeeding to be unadvisable during tofacitinib use at this time. The manufacturer and an expert panel recommend that breastfeeding be discontinued during tofacitinib therapy and for 18 hours after the last dose of the immediate-release product or 36 hours after the last dose of the sustained-release product.
National Institute of Child Health and Human Development, record revised July 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about tofacitinib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 7,341 reports naming tofacitinib, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- rheumatoid arthritis2,695 reports
- fatigue2,503 reports
- rash2,413 reports
- drug intolerance2,388 reports
- systemic lupus erythematosus2,284 reports
- hand deformity2,278 reports
- joint swelling2,278 reports
- glossodynia2,239 reports
Read these as a signal, not a rate. A report does not mean tofacitinib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is Xeljanz?
XELJANZ (tofacitinib) tablets, XELJANZ XR (tofacitinib) extended-release tablets and XELJANZ (tofacitinib) oral solution are formulated with the citrate salt of tofacitinib, a JAK inhibitor.
What kind of drug is tofacitinib?
The FDA classifies tofacitinib as a janus kinase inhibitor. JAK inhibitors block Janus kinase enzymes inside immune cells. These enzymes normally pass along messages from inflammatory signals (cytokines) to relay proteins that switch on genes, so blocking them turns down the overactive immune signaling that drives diseases like rheumatoid arthritis. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take tofacitinib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run tofacitinib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is tofacitinib sold under?
We track 2 tofacitinib-containing products in the U.S.: Xeljanz and Tofacitinib Citrate. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does tofacitinib come in?
Across the brands we track, tofacitinib is currently marketed as solution, tablet and tablet, extended release, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic tofacitinib?
Yes. Our catalog lists 1 generic tofacitinib product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Tofacitinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/tofacitinib
- MLA
- “Tofacitinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/tofacitinib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for tofacitinib on DailyMed (NIH) ↗ — including its boxed warning in full.