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Tofacitinib

Tofacitinib is a Janus kinase (JAK) inhibitor taken by mouth for inflammatory conditions: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis and, in children, juvenile idiopathic arthritis.

Brand names XeljanzXeljanz Xr
Drug class Janus Kinase Inhibitors
Rx Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 31 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Tofacitinib at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Tofacitinib (Xeljanz) is an oral drug that blocks JAK enzymes, which relay inflammation signals. On the market since about 2012 and available generically, it treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis and some childhood arthritis, usually after a TNF blocker such as Humira has failed or was not tolerated. Most people tolerate it fairly well, noticing mainly colds, diarrhea or headache, though it makes shingles more likely. Its boxed warning covers serious infections including tuberculosis, cancer, heart attack, stroke, blood clots and death, with risk highest at 50-plus with heart risk factors or a smoking history, so report fever, chest pain, leg swelling or sudden breathlessness promptly.

Clinical pearls

  • Expect tuberculosis and hepatitis testing before starting, plus regular blood work for blood counts, liver enzymes and cholesterol.
  • Get vaccines updated before starting, since live vaccines must be avoided once you are taking tofacitinib.
  • Rifampin can stop it working, while ketoconazole or fluconazole raise its levels, so flag any new antibiotic or antifungal.
  • Xeljanz XR is not interchangeable with the regular tablets or liquid, so never swap forms without your prescriber.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Tofacitinib can cause serious infections, including tuberculosis, that may lead to hospitalization or death. It can also raise the risk of death, cancers (including lymphoma and lung cancer), major heart events such as heart attack and stroke, and dangerous blood clots in the legs, lungs or arteries.

These risks were highest in people with rheumatoid arthritis who were 50 or older with at least one heart risk factor, and in current or past smokers. Watch for fever, cough, chest pain, leg swelling, sudden shortness of breath, or stroke symptoms. Your doctor will test for tuberculosis before and during treatment and may stop the medicine if a serious problem develops.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Extended-release tablet, Oral solution
Earliest FDA record2012
Companies listing it with the FDA24
FDA label last updatedJul 13, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Tofacitinib, written from its FDA label.

What Tofacitinib is used for

▾

Tofacitinib is used for several inflammatory conditions, depending on the product.

  • Adults with moderately to severely active rheumatoid arthritis after a TNF blocker did not work or was not tolerated (tablets and extended-release tablets).
  • Adults with active psoriatic arthritis, same condition (tablets, extended-release tablets).
  • Adults with active ankylosing spondylitis, same condition (tablets, extended-release tablets).
  • Adults with moderately to severely active ulcerative colitis, same condition (tablets and extended-release tablets).
  • Children 2 and older with active psoriatic arthritis (Xeljanz and tofacitinib tablets and oral solution).
  • Children 2 and older with active polyarticular course juvenile idiopathic arthritis (Xeljanz and tofacitinib tablets and oral solution).

How Tofacitinib works

▾

Tofacitinib is a JAK inhibitor. JAK enzymes inside cells relay signals from immune messengers called cytokines. Tofacitinib blocks this relay, which prevents the activation of proteins called STATs that turn on immune and inflammatory activity. This lowers inflammation, though which JAK pairings matter most for its benefit is not known.

Tofacitinib dosage

▾

Tofacitinib is taken by mouth as a tablet, extended-release tablet, or oral solution.

  • Regular tablets and oral solution are taken twice daily; extended-release tablets once daily.
  • It was given without regard to meals in trials.
  • Extended-release tablets are not interchangeable with Xeljanz tablets or oral solution; only your provider should switch you.
  • Before starting, your provider may check for tuberculosis and hepatitis, run blood counts, and update vaccines.

Follow your prescriber's directions and the label for your dose.

Dosing details from the FDA-approved label

From the Tofacitinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adult Patients with RA, PsA or AS (normal renal and hepatic function)
    • Tofacitinib extended-release tablets 11 mg once daily
  • Adult Patients with UC - Induction
    • Tofacitinib extended-release tablets 22 mg once daily for 8 weeks
    • Evaluate patients and transition to maintenance therapy depending on therapeutic response
    • If needed, continue 22 mg once daily for a maximum of 16 weeks
    • Discontinue 22 mg once daily after 16 weeks if adequate therapeutic response is not achieved
    • Maximum: 16 weeks
  • Adult Patients with UC - Maintenance
    • Tofacitinib extended-release tablets 11 mg once daily
    • For patients with loss of response during maintenance treatment, 22 mg once daily may be considered and limited to the shortest duration, with careful consideration of the benefits and risks for the individual patient
    • Use the lowest effective dose needed to maintain response
  • Mild RI (CLcr > 50 and ≤ 80 mL/min) in RA, PsA or AS
    • 11 mg once daily
  • Moderate RI (CLcr ≥ 30 and ≤ 50 mL/min) in RA, PsA or AS
    • XELJANZ tablets 5 mg once daily
    • For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days
  • Severe RI (CLcr < 30 mL/min) in RA, PsA or AS
    • XELJANZ tablets 5 mg once daily
    • For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days
  • Mild HI (Child-Pugh A) in RA, PsA or AS
    • 11 mg once daily
  • Moderate HI (Child-Pugh B) in RA, PsA or AS
    • XELJANZ tablets 5 mg once daily
  • Severe HI (Child-Pugh C)
    • Use of XELJANZ tablets/tofacitinib extended-release tablets is not recommended
  • RA, PsA or AS with strong CYP2C19 inhibitor(s)
    • 11 mg once daily
    • Dosage modification with concomitant CYP2C19 inhibitor(s)
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 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 daily or XELJANZ XR 22 mg once daily after 16 weeks if adequate therapeutic response is not achieved. ( 2.5 ) • Maintenance: XELJANZ tablets 5 mg twice daily or XELJANZ XR 11 mg once daily. For patients with loss of response during maintenance treatment, XELJANZ tablets 10 mg twice daily or XELJANZ XR 22 mg once daily may be considered and limited to the shortest duration, with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dose needed to maintain response. ( 2.5 ) Dosage in Patients with Renal Impairment or Hepatic Impairment • Use of XELJANZ (tablets and oral solution) or XELJANZ XR in patients with severe HI is not recommended. ( 2.3 , 2.4 , 2.5 , 8.7 ) • See full prescribing information (FPI) for recommended dosage in patients with moderate or severe RI or moderate HI.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Tofacitinib side effects

▾

The most commonly reported side effects include:

Common side effects

  • Upper respiratory tract infection (cold-like symptoms)
  • Nasopharyngitis (stuffy, sore nose and throat)
  • Diarrhea
  • Headache
  • Rash
  • Shingles (herpes zoster)
  • Higher cholesterol levels (seen in ulcerative colitis)
  • Increased blood creatine phosphokinase (a muscle enzyme, seen in ulcerative colitis)

When to get medical help

  • Call your doctor right away for signs of infection, such as fever, chills, cough, or sores that won't heal. Serious infections, including tuberculosis, can be life-threatening.
  • Get emergency help for symptoms of a heart attack or stroke. Tofacitinib should be stopped if you have one.
  • Get urgent help for symptoms of a blood clot, such as leg swelling or pain, sudden shortness of breath, or chest pain.
  • Tell your doctor about new or unexplained lumps, swollen glands, or skin changes, since cancers including lymphoma and skin cancer have been reported.
  • Call your doctor for new belly pain, especially if you have had diverticulitis or take NSAIDs, because of the risk of a tear in the stomach or bowel.
  • Seek help for allergic reactions such as swelling of the face, lips or tongue (angioedema).
  • If you have diabetes, report signs of low blood sugar.

Serious infections, blood clots, heart events, and cancers can occur. Seek medical help right away if you notice warning signs.

Tofacitinib warnings and precautions

▾
  • Serious infections: including tuberculosis, fungal, and viral infections such as shingles. Avoid starting during an active serious infection. Treatment is interrupted if one develops.
  • Death, heart attack, and stroke: higher rates than TNF blockers in rheumatoid arthritis patients 50 or older with a heart risk factor.
  • Cancer: including lymphoma, lung cancer, and skin cancer. Smokers face added risk.
  • Blood clots: in legs, lungs and arteries.
  • Stomach or bowel tears: report new belly symptoms promptly.
  • Lab changes: low lymphocytes, neutrophils, and hemoglobin, raised liver enzymes and lipids, so monitoring is recommended.
  • Low blood sugar may occur in people with diabetes.

Tofacitinib interactions

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Some medicines change tofacitinib levels or add to immune suppression.

  • Strong CYP3A4 inhibitors such as ketoconazole raise levels; a dose change is recommended.
  • Moderate CYP3A4 inhibitors combined with strong CYP2C19 inhibitors such as fluconazole raise levels; a dose change is recommended.
  • Strong CYP3A4 inducers such as rifampin lower levels and may reduce effect; not recommended.
  • Azathioprine, tacrolimus, cyclosporine and biologic DMARDs add immune suppression; not recommended.
  • Live vaccines should be avoided.

Interactions listed in the FDA-approved label

From the Tofacitinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A4 Inhibitors (e.g., ketoconazole): Increased exposure to tofacitinib Dosage modification of tofacitinib extended-release tablet is recommended
  • Moderate CYP3A4 Inhibitors concomitantly used with Strong CYP2C19 Inhibitors (e.g., fluconazole): Increased exposure to tofacitinib Dosage modification of tofacitinib extended-release tablet is recommended
  • Strong CYP3A4 Inducers (e.g., rifampin): Decreased exposure to tofacitinib and may result in loss of or reduced clinical response Concomitant use with tofacitinib extended-release tablet is not recommended
  • Immunosuppressive Drugs (e.g., azathioprine, tacrolimus, cyclosporine): Risk of added immunosuppression; concomitant use with biologic DMARDs or potent immunosuppressants has not been studied in patients with RA, PsA, AS or UC Concomitant use with tofacitinib extended-release tablet is not recommended
Read the label’s full interactions text

7 DRUG INTERACTIONS Table 7 includes drugs with clinically significant drug interactions when concomitantly used with tofacitinib extended-release tablets and instructions for preventing or managing them. Table 7 Clinically Significant Interactions Affecting Tofacitinib extended-release tablets When Concomitantly Used with Other Drugs Strong CYP3A4 Inhibitors (e.g., ketoconazole) Clinical Impact Increased exposure to tofacitinib Intervention Dosage modification of tofacitinib extended-release tablet 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 tofacitinib extended-release tablet 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 tofacitinib extended-release tablet 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 tofacitinib extended-release tablets with biologic DMARDs or potent immunosuppressants has not been studied in patients with RA, PsA, AS or UC. Intervention Concomitant use with tofacitinib extended-release tablet is not recommended [see Indications and Usage (1), Clinical Pharmacology, Figure 3 ( 12.3 )] See FPI for clinically significant drug interactions. ( 2 , 7 )

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿184 supplements and herbs with documented Tofacitinib interactions, ranked by severity Check Tofacitinib against a supplement or herb →

Before taking Tofacitinib

▾
  • No contraindications are listed, but tell your doctor about any current, chronic, or recurrent infection.
  • Mention tuberculosis exposure or travel to areas where tuberculosis or fungal infections are common.
  • Mention smoking history, heart disease risk factors, past cancer, or blood clots.
  • Mention diverticulitis, NSAID use, chronic lung disease, or diabetes.
  • Pregnancy: data are insufficient; animal studies showed harm and possible reduced fertility in females.
  • Breastfeeding is not recommended during treatment and for at least 18 hours after the last Xeljanz dose or 36 hours after the last Xeljanz XR dose.
  • Children: Xeljanz tablets and oral solution are studied from age 2 for psoriatic arthritis and polyarticular course juvenile idiopathic arthritis; extended-release tablets are not established in children.

Tofacitinib overdose

▾

There is no specific antidote for tofacitinib overdose. A person who takes too much should be watched for signs and symptoms of side effects. Dialysis removes only a small share of the drug. Contact Poison Help at 1-800-222-1222 or a medical toxicologist for guidance.

What Tofacitinib does in the body

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Tofacitinib lowers natural killer cell counts in a dose-dependent way, with the biggest drop around 8 to 10 weeks, and these recover within 2 to 6 weeks after stopping. B cell counts rise, while T cell changes are small and inconsistent. In rheumatoid arthritis, the inflammation marker CRP drops quickly and stays low during treatment.

How your body processes Tofacitinib

▾

Regular tablets and oral solution peak in about 0.5 to 1 hour and have a half-life of about 3 hours. Extended-release tablets peak at about 4 hours with a half-life of about 6 to 8 hours. About 70% of the drug is cleared by liver metabolism, mainly through CYP3A4, and about 30% by the kidneys. A high-fat meal did not change overall exposure.

How to store Tofacitinib

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for XELJANZ Tablets/XELJANZ XR Store XELJANZ tablets and XELJANZ XR at 20°C to 25°C (68°F to 77°F). for XELJANZ Oral Solution Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

184

Supplements & herbs that interact with Tofacitinib

184 supplements and herbal products have documented interactions with Tofacitinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 143
  • Minor · 38
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ACTIVE HEXOSE CORRELATED COMPOUND (AHCC) Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate ALFALFA Moderate +176 more
Every supplement checked against Tofacitinib — ranked by severity The full interaction hub: 3 major · 143 moderate · 38 minor · every one linked to its full report. Check Tofacitinib against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Tofacitinib: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Tofacitinib — the kind of thing our pharmacy team would talk through with you at the counter.

What is tofacitinib for?

▾
It treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adults, usually after a TNF blocker didn't work or wasn't tolerated. Xeljanz and tofacitinib tablets and oral solution are also used in children 2 and older for certain arthritis types.

How do I take it?

▾
You take it by mouth. Tablets and solution are usually taken twice a day, and extended-release tablets once a day. It can be taken with or without food. Follow your prescriber's directions, and never switch between forms on your own.

What side effects should I expect?

▾
Colds, stuffy or sore nose and throat, diarrhea, and headache are most common. Some people with ulcerative colitis also get rash, shingles, or higher cholesterol. Call your doctor if you notice signs of infection, such as fever or cough.

When should I get urgent help?

▾
Get help right away for chest pain, stroke symptoms, sudden shortness of breath, or leg swelling and pain, which can signal a clot or heart problem. Also report new belly pain, signs of infection, or swelling of the face or tongue.

Can I take it with my other medicines?

▾
Tell me about everything you take. Antifungals like ketoconazole or fluconazole can raise tofacitinib levels, while rifampin can lower them. Other immune-suppressing drugs and biologics generally shouldn't be combined with it, and you should avoid live vaccines.

Is it safe in pregnancy or while breastfeeding?

▾
There isn't enough human data to know the pregnancy risk, and animal studies showed harm, so talk with your doctor if you're pregnant or planning to be. Breastfeeding isn't recommended during treatment and for a period after the last dose.

Is Tofacitinib available over the counter?

▾
No. Tofacitinib is a prescription medicine: every Tofacitinib product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Tofacitinib first available?

▾
The earliest FDA record we hold for Tofacitinib is from 2012: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Tofacitinib was first used.

Who makes Tofacitinib?

▾
24 companies currently list Tofacitinib products in the FDA's NDC Directory, including Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals, Zydus Lifesciences Limited. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Tofacitinib on HelloPharmacist

📊Tofacitinib supplement interactions184 checked — ranked by severity 🌿Drug & Supplement CheckerTofacitinib vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Tofacitinib NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Tofacitinib Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Tofacitinib forms and strengths (how it comes)

Tofacitinib is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Xeljanz
How this form is used
What it may be used for
  • Xeljanz and tofacitinib tablets are for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis after a TNF blocker did not work or was not tolerated.
  • Xeljanz and tofacitinib tablets are also for children 2 years and older with active psoriatic arthritis or polyarticular course juvenile idiopathic arthritis.
Important instructions
  • Xeljanz tablets are taken by mouth, generally twice daily.
  • Xeljanz and tofacitinib tablets were given without regard to meals in clinical trials.
  • For ulcerative colitis, Xeljanz tablets should not be combined with biological therapies for ulcerative colitis or potent immunosuppressants.
Available strengths 2 strengths
5 mg 10 mg
62 FDA-listed product records ⓘ

Extended-release tablet

By mouth
Brands Xeljanz
How this form is used
What it may be used for
  • Xeljanz XR and tofacitinib extended-release tablets are for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis after a TNF blocker did not work or was not tolerated.
  • Xeljanz XR and tofacitinib extended-release tablets are not labeled for children.
Important instructions
  • Tofacitinib extended-release tablets are taken once daily.
  • Tofacitinib Citrate extended-release tablets are not substitutable with Xeljanz tablets or oral solution; a healthcare provider should make any switch.
  • Xeljanz XR and tofacitinib extended-release tablets can be taken with or without food, since a high-fat meal did not change overall drug exposure.
Available strengths 2 strengths
11 mg 22 mg
40 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Xeljanz
How this form is used
What it may be used for
  • Tofacitinib oral solution is for children 2 years and older with active psoriatic arthritis after a TNF blocker did not work or was not tolerated.
  • Tofacitinib oral solution is for children 2 years and older with active polyarticular course juvenile idiopathic arthritis after a TNF blocker did not work or was not tolerated.
Important instructions
  • Xeljanz oral solution is taken by mouth; follow the prescriber's directions and label for the amount.
  • Tofacitinib oral solution should not be combined with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine.
Available strengths 1 strength
1 mg/mL
15 FDA-listed product records ⓘ

Tofacitinib on the U.S. market: products, makers and brands

How Tofacitinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

24 companies list 51 Tofacitinib product records with the FDA, mostly as tablet, extended-release tablet, oral solution; the earliest marketing or approval year on record is 2012. Brand names on the directory include Xeljanz, Xeljanz Xr; the rest are generics.

3
Dose forms ⓘ
24
Labelers (makers, repackagers, distributors)
6
Brand names
51
FDA-listed product records ⓘ
2012
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (33) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Pfizer Laboratories Div Pfizer Inc10%
U.S. Pharmaceuticals10%
Zydus Lifesciences Limited8%
Zydus Pharmaceuticals USA Inc.8%
Apotex Corp.6%
Aurobindo Pharma Limited6%
Other makers53%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Tofacitinib is used (Medicaid data)

A general measure of how commonly Tofacitinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Tofacitinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

41,140
Medicaid prescriptions filled (Q1–Q4 2025)
$254.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tofacitinib prescribed? Of the 1,601 medications we measure, Tofacitinib ranks #672 by Medicaid prescriptions — more than 58% of them.

Where Tofacitinib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #672 of 1,601
#667 Ivabradine 42,299 Rx #668 Prucalopride 42,108 Rx #669 Gadoterate Meglumine 42,002 Rx #670 Linezolid 41,650 Rx #671 Trospium 41,279 Rx #672 Tofacitinib 41,140 Rx #673 Gentamicin Topical 41,105 Rx #674 Carbinoxamine 40,978 Rx #675 Estradiol / Norethindr... 40,957 Rx #676 Dapagliflozin / Metfor... 40,800 Rx #677 Calcium Gluconate 40,321 Rx

Utilization by Tofacitinib product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 11 mg 24 hr extended release oral tablet is the most-dispensed Tofacitinib product — about 50% of these Medicaid prescriptions.

24 HR tofacitinib 11 MG Extended Release Oral Tablet Most dispensed

20,442 Medicaid prescriptions (Q1–Q4 2025) 50% of Tofacitinib prescriptions shown $130.9M gross reimbursement (before rebates) ≈ $6,405 per prescription (gross)

Summed across the 1 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1741046

tofacitinib 5 MG Oral Tablet

16,429 Medicaid prescriptions (Q1–Q4 2025) 40% of Tofacitinib prescriptions shown $100.3M gross reimbursement (before rebates) ≈ $6,108 per prescription (gross)

Summed across the 1 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1357541

tofacitinib 10 MG Oral Tablet

2,978 Medicaid prescriptions (Q1–Q4 2025) 7% of Tofacitinib prescriptions shown $16.4M gross reimbursement (before rebates) ≈ $5,509 per prescription (gross)

Summed across the 1 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2048566

tofacitinib 1 MG/ML Oral Solution

1,235 Medicaid prescriptions (Q1–Q4 2025) 3% of Tofacitinib prescriptions shown $6.8M gross reimbursement (before rebates) ≈ $5,535 per prescription (gross)

Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2478433

24 HR tofacitinib 22 MG Extended Release Oral Tablet

56 Medicaid prescriptions (Q1–Q4 2025) <1% of Tofacitinib prescriptions shown $361,218 gross reimbursement (before rebates) ≈ $6,450 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2273113

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tofacitinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 80 listed Tofacitinib NDCs with Medicaid activity.

Compare Tofacitinib products

A representative set of FDA-listed product records for Tofacitinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 51 of 51 products — FDA National Drug Code Directory. See every product, package size and price: browse all 51 Tofacitinib NDCs →

Tofacitinib recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Tofacitinib recalls since July 2021.

✅No Tofacitinib recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Tofacitinib RxCUI 1357536 3 dose forms · 5 strengths
  2. Dose form (SCDF) Oral Solution RxCUI 2478432 In current FDA listings
    Clinical drug / strength (SCD) 1 MG/ML RxCUI 2478433
  3. Dose form (SCDF) Oral Tablet RxCUI 1357540 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 1357541 10 MG RxCUI 2048566

Look up RxCUI 1357536 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Tofacitinib costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 10 mg $103.94 per tablet NDC details & price history
Tablet, Film Coated · Oral 5 mg $73.77 per tablet NDC details & price history
Tablet, Film Coated, Extended Release · Oral 11 mg $207.90 per tablet NDC details & price history
Tablet, Extended Release · Oral 11 mg $2.19 per tablet NDC details & price history
Tablet · Oral 5 mg $0.573 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Tofacitinib brand names

Tofacitinib is sold under 2 brand names in the FDA directory — Xeljanz, Xeljanz Xr. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Xeljanz Xeljanz Xr

Who makes Tofacitinib: manufacturers and labelers

24 companies list Tofacitinib products with the FDA. By number of product records, the largest are Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals, Zydus Lifesciences Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Pfizer Laboratories Div Pfizer Inc 5 U.S. Pharmaceuticals 5 Zydus Lifesciences Limited 4 Zydus Pharmaceuticals USA Inc. 4 Apotex Corp. 3 Aurobindo Pharma Limited 3 AvKARE 3 Novadoz Pharmaceuticals LLC 3 Breckenridge Pharmaceutical, Inc. 2 Golden State Medical Supply, Inc. 2 Macleods Pharmaceuticals Limited 2 Micro Labs Limited 2 Somerset Therapeutics, LLC 2 Ajanta Pharma USA Inc. 1 Biocon Pharma Inc 1 Edenbridge Pharmaceuticals LLC. 1 Exelan pharmaceuticals,Inc 1 Hikma Pharmaceuticals USA Inc. 1 IPG Pharmaceuticals, Inc 1 Orient Pharma Co., Ltd. Yunlin Plant 1 Padagis US LLC 1 Radha Pharmaceuticals, Inc. 1 ScieGen Pharmaceuticals, INC. 1 Sun Pharmaceutical Industries, Inc. 1

Tofacitinib drug class (RxNorm)

Tofacitinib belongs to the Janus Kinase Inhibitor class.

Pharmacologic class Janus Kinase Inhibitor
Drug family (ATC) Janus-associated kinase (JAK) inhibitors
How it works Janus Kinase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Tofacitinib page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 13, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tofacitinib.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Tofacitinib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
31
Finished products in the current FDA directory
51
Companies listing them (makers, repackagers, distributors)
24
FDA labeler codes behind them ⓘ
24
Linked representative label ⓘ
U.S. Pharmaceuticals
Linked label effective
Jul 13, 2026
Composite sections available
25
Linked SPL Set ID
68e3d6b2-7838-4d2d-a417-09d919b43e13
Linked SPL Document ID
e8ed9fec-0cc3-403c-a731-72a6f8969afa
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. U.S. Pharmaceuticals is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →