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Safety & Tolerability

Real World Experience

Support & Resources

Information on how to access XELJANZ®▼ (tofacitinib citrate) prescribing information and adverse event reporting can be found at the bottom of the page.

Safety Profile

XELJANZ demonstrates a consistent safety profile in PsA - building on experience in RA1-8

  • XELJANZ has been studied in two large Phase III PsA clinical trials1–4 and one LTE study up to 4 years, and shows a safety profile consistent with that observed in RA5,6
  • A clinical trial programme in RA, including LTE studies up to 9.5 years5
  • Real-world experience: XELJANZ has been prescribed to over 208,000 patients across indications worldwide7 

System organ class

Common (>1/100 to <1/10)

Infections and infestations

Pneumonia, influenza, herpes zoster, urinary tract infection, sinusitis, bronchitis, nasopharyngitis, pharyngitis

Blood and lymphatic system disorders


Nervous system disorders


Vascular disorders


Respiratory, thoracic and mediastinal disorders


Gastrointestinal disorders

Abdominal pain, vomiting, diarrhoea, nausea, gastritis, dyspepsia

Skin and subcutaneous tissue disorders​​​​​​​


Musculoskeletal and connective tissue disorders


General disorders and administration site conditions

Oedema peripheral, pyrexia, fatigue


Blood creatine phosphokinase increased

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Dosing in PsA

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LTE=long-term extension; PsA=psoriatic arthritis; RA = rheumatoid arthritis

  1. Mease P et al. N Engl J Med 2017; 377: 1537–1550.
  2. Mease P et al. N Engl J Med 2017; 377: 1537–1550 (supplementary appendix).
  3. Gladman D et al. N Engl J Med 2017; 377: 1525–1536.
  4. Gladman D et al. N Engl J Med 2017; 377: 1525–1536 (supplementary appendix).
  5. Wollenhaupt J et al. Poster presented at: American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting; November 3–8, 2017; San Diego, CA, USA.
  6. Nash P et al. Lancet Rehumatol. 2021;3(4):E27-E283.
  7. Cohen SB et al. Lancet Rheumatol. 2019; 1:e23-e34.
  8. XELJANZ (tofacitinib citrate) Summary of Product Characteristics.
PP-XEL-GBR-2320. June 2021


XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from Patients treated with XELJANZ should be given the Patient Alert Card.

Clinical Efficacy PsA

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For UK Healthcare Professionals*

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PP-PFE-GBR-3863. November 2021