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Tofacitinib

Tofacitinib is an active ingredient of the class «immunosuppressive drug».

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Chemical compound

Informational only — not medical advice. Ask a doctor or pharmacist; never change a dose on your own.

Boxed warning (US label)

SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS • Increased risk of serious bacterial, fungal, viral, and…

What it is used for

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…

US label

Rheumatoid arthritisTofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying…

EMA

How it works

Class: immunosuppressive drug

Common side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections • Increased Risk of Mortality • Malignancy and Lymphoproliferative Disorders • Major Adverse Cardiovascular Events • Thrombosis • Gastrointestinal Perforations • Hypersensitivity Reactions •…

US label

Pregnancy and breastfeeding

The available data with XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) from a pregnancy exposure registry that enrolled 11 exposed pregnant females, pharmacovigilance, and published literature are insufficient to draw…

Excerpts from the US prescribing label (public domain), copied without changes.

Brand names

United States

Xeljanz · Xeljanz XR

European Union

Xeljanz

Canada

Apo-Tofacitinib · Auro-Tofacitinib · Devatis Tofacitinib · Jamp Tofacitinib · Pms-Tofacitinib · Sandoz Tofacitinib · Taro-Tofacitinib · Taro-Tofacitinib XR · Xeljanz · Xeljanz XR

Approval status

US Food and Drug Administration
prescription · since 2012
European Medicines Agency
authorised · since 2017
Health Canada
prescription · marketed
First approval anywhere
2012

Codes

ATC
L04AA29, L04AF01
RxNorm CUI
1357536
ChEMBL
CHEMBL221959
PubChem CID
9926791
UNII
87LA6FU830
Wikidata
Q3530324

Frequently asked questions

What is Tofacitinib used for?

Tofacitinib is used for: Polyarthritis, Osteoarthritis susceptibility 1, Alopecia areata, Bald head, Arthritis, Ulcerative colitis, Rheumatoid arthritis, and Psoriatic arthritis.

What kind of medicine is Tofacitinib?

Tofacitinib is an active ingredient of the class «immunosuppressive drug».

What are the brand names of Tofacitinib?

Brand names of Tofacitinib include Xeljanz, Xeljanz XR, Apo-Tofacitinib, Auro-Tofacitinib, Devatis Tofacitinib, Jamp Tofacitinib, Pms-Tofacitinib, and Sandoz Tofacitinib.

Medicines in the same class

Sources and licences

Updated November 15, 2026