Prescription medicine
Tofacitinib Brand names: Xeljanz
Tofacitinib (Xeljanz) is a prescription medicine with an FDA approval on record since 2012. FDA's NDC Directory lists it from 24 generic labelers, and pharmacies paid $0.573 per tofacitinib 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the tofacitinib FDA label on DailyMed (effective July 13, 2026, U.S. Pharmaceuticals); the NDA 203214 record on Drugs@FDA; every tofacitinib label on DailyMed.
Highlights of the record
FDA label of July 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS,.
and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS See full prescribing information for complete boxed warning.
Increased risk of serious bacterial, fungal, viral, and opportunistic infections, including tuberculosis (TB), leading to hospitalization or death. Interrupt XELJANZ/XELJANZ XR treatment if serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative latent TB test. ( 5.1 )
Higher rate of all-cause mortality, including sudden cardiovascular (CV) death with XELJANZ vs. TNF blockers in rheumatoid arthritis (RA) patients. ( 5.2 )
Malignancies have occurred in patients treated with XELJANZ. Higher rate of lymphomas and lung cancers with XELJANZ vs. TNF blockers in RA patients. ( 5.3 )
Higher rate of major adverse CV events (defined as CV death, myocardial infarction, and stroke) with XELJANZ vs. TNF blockers in RA patients. ( 5.4 )
Thrombosis has occurred in patients treated with XELJANZ. Increased incidence of pulmonary embolism, venous and arterial thrombosis with XELJANZ vs. TNF blockers in RA patients. […]
Used for
From the label: indications and usageXELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) are Janus kinase (JAK) inhibitors.
Forms and strengths
- 5 mg
- 8.08 mg
- 10 mg
- 11 mg
- 16.16 mg
- 22 mg
- 1 mg/ml
Film-coated tablet; film-coated extended-release tablet; solution; extended-release tablet; tablet.
On the market
- Earliest approval on file
- November 6, 2012 Xeljanz, Pf Prism Cv; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first June 1, 2021; 27 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 26 of which 24 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- June 8, 2026 Xeljanz tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.573 per tablet Tofacitinib 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 186,746 through July 30, 2026
What is tofacitinib used for?
From the label: indications and usageXELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) are Janus kinase (JAK) inhibitors. XELJANZ tablets and XELJANZ XR are indicated for the treatment of adult patients with:
Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers.
Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.
Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. […]
Conditions named in the indications of tofacitinib's FDA labels, with every medicine labeled for each:
From other tofacitinib labelsRheumatoid arthritis: Rheumatoid Arthritis XELJANZ tablets and XELJANZ XR (extended-release tablets) are indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or …
Crohn's disease and ulcerative colitis: Ulcerative Colitis XELJANZ tablets and XELJANZ XR (extended-release tablets) are indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to …
FDA pharmacologic class: Janus Kinase Inhibitor.
Source: FDA drug label (XELJANZ), NDA203214 (Pf Prism Cv), as published by U.S. Pharmaceuticals, effective July 13, 2026 (SPL set 68e3d6b2-7838-4d2d-a417-09d919b43e13), via openFDA; the full label on DailyMed
What does the patient leaflet for tofacitinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about XELJANZ/XELJANZ XR/XELJANZ oral solution?XELJANZ/XELJANZ XR/XELJANZ oral solution may cause serious side effects including: 1. Serious infections. XELJANZ/XELJANZ XR/XELJANZ oral solution are medicines that affect your immune system. XELJANZ/XELJANZ XR/XELJANZ oral solution can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR/XELJANZ oral solution, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. • Your healthcare provider should test you for TB before starting XELJANZ/XELJANZ XR/XELJANZ oral solution and during treatment. • Your healthcare provider should monitor you closely for signs and symptoms of TB infection during treatment with XELJANZ/XELJANZ XR/XELJANZ oral solution. You should not start taking XELJANZ/XELJANZ XR/XELJANZ oral solution if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). People with ulcerative colitis taking the higher dose of XELJANZ (10 mg twice daily) or XELJANZ XR (22 mg one time each day) have a higher risk of serious infections and shingles. Before starting XELJANZ/XELJANZ XR/XELJANZ oral solution, tell your healthcare provider if you: • think you have an infection or have symptoms of an infection such as: o fever, sweating, or chills o cough o blood in phlegm o warm, red, or painful skin or sores on your body o burning when you urinate or urinating more often than normal o muscle aches o shortness of breath o weight loss o diarrhea or stomach pain o feeling very tired • are being treated for an infection. • get a lot of infections or have infections that keep coming back. […]
From the patient leaflet: How should I store XELJANZ/XELJANZ XR/XELJANZ oral solution?Store XELJANZ/XELJANZ XR at room temperature between 68°F to 77°F (20°C to 25°C). • Store XELJANZ oral solution at room temperature between 68°F to 77°F (20°C to 25°C) in the original bottle and carton to protect from light. • Safely throw away XELJANZ oral solution that is out of date or no longer needed. Use XELJANZ oral solution within 60 days of opening the bottle. Throw away (discard) remaining oral solution after 60 days. Keep XELJANZ/XELJANZ XR/XELJANZ oral solution and all medicines out of the reach of children.
Source: FDA drug label (XELJANZ), NDA203214 (Pf Prism Cv), as published by U.S. Pharmaceuticals, effective July 13, 2026 (SPL set 68e3d6b2-7838-4d2d-a417-09d919b43e13), via openFDA; the full label on DailyMed
Is there a generic for tofacitinib (Xeljanz)?
The FDA approved the first generic tofacitinib on June 1, 2021. 27 generic applications are approved; 27 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 5 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists tofacitinib from 24 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Xeljanz tablets: the compound patent runs to December 8, 2025 (pediatric exclusivity to June 8, 2026); a patent listed only for Xeljanz XR tablets runs to September 14, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2021 first generic approved
- 2026 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tofacitinib (Xeljanz)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.573 per Tofacitinib 5 mg tablet. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tofacitinib 5 mg tablet (generic)
- Xeljanz 5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tofacitinib 5 mg tablet | Generic | $0.573 per tablet | $17.18 | n/a |
| Tofacitinib ER 11 mg tablet | Generic | $2.19 per tablet | $65.78 | n/a |
| Xeljanz 10 mg tablet | Brand | $103.94 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $3,118.15 | +6% |
| Xeljanz 5 mg tablet | Brand | $73.77 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $2,213.15 | -25% |
| Xeljanz XR 11 mg tablet | Brand | $207.90 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $6,236.89 | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the tofacitinib label say about other medicines?
The tofacitinib label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name tofacitinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Azathioprine | drug interactions | … 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; … |
| Cyclosporine | drug interactions | … 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 … |
| Fluconazole | drug interactions | … 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 … |
| Ketoconazole | drug interactions | 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 … |
| Methotrexate | boxed warning | Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. |
| Rifampin | drug interactions | … [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 … |
| Tacrolimus | drug interactions | … 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 … |
Other labels that name tofacitinib
Source: FDA drug label (XELJANZ), NDA203214 (Pf Prism Cv), as published by U.S. Pharmaceuticals, effective July 13, 2026 (SPL set 68e3d6b2-7838-4d2d-a417-09d919b43e13), via openFDA; the full label on DailyMed
What do FAERS reports show for tofacitinib?
The FDA Adverse Event Reporting System holds 186,746 reports that list tofacitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9,652 are coded as a death and 26,629 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tofacitinib?
10 other medicines are given the same way (oral) and in the same FDA class as tofacitinib or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Upadacitinib | Rheumatoid arthritis, Crohn's disease and ulcerative colitis | none listed | $229.31 per tablet 15 mg tablet | No current entry |
| Baricitinib | Rheumatoid arthritis | none listed | $92.54 per tablet 2 mg tablet | No current entry |
| Indomethacin | Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
| Hydroxychloroquine | Rheumatoid arthritis | 28 labelers | $0.149 per tablet 200 mg tablet | A presentation being discontinued |
| Leflunomide | Rheumatoid arthritis | 16 labelers | $0.324 per tablet 10 mg tablet | A presentation being discontinued |
| Methotrexate | Rheumatoid arthritis | 25 labelers | $0.158 per tablet 2.5 mg tablet | In shortage |
| Sulfasalazine | Rheumatoid arthritis, Crohn's disease and ulcerative colitis | 5 labelers | $0.199 per tablet 500 mg tablet | No current entry |
| Penicillamine | Rheumatoid arthritis | 9 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as tofacitinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tofacitinib compare with medicines for the same use?
2 side-by-side pages set tofacitinib beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tofacitinib
- 10 medicines for the same use
- Other janus kinase inhibitors
- the pharmacologic class, with prices and generics
- Tofacitinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other