Common Side Effects of Xeljanz
Xeljanz (tofacitinib), used for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis, often causes headaches, diarrhea, upper respiratory infections, and nasopharyngitis. Other frequent issues include high blood pressure, nausea, and elevated cholesterol levels.[1][2]
Serious Side Effects and Black Box Warnings
It carries FDA black box warnings for increased risk of serious infections (such as tuberculosis, shingles, or fungal infections), death, heart-related events (like heart attack or stroke), cancer (including lymphoma and lung cancer), blood clots (deep vein thrombosis or pulmonary embolism), and tears in the stomach or intestines. These risks rise with higher doses, longer use, or in patients over 50 with cardiovascular risk factors.[1][2][3]
Side Effects by Condition or Dosage
In rheumatoid arthritis trials, infections affected 20-25% of patients, with herpes zoster at 4%. For ulcerative colitis, similar patterns hold, plus higher rates of cytomegalovirus infections. At 10 mg twice daily (used short-term for UC flares), risks like clots and malignancies double compared to 5 mg doses.[2][3]
What Increases Side Effects Risk?
Smoking, age over 65, heart disease history, or combining with other immunosuppressants heightens dangers. Avoid live vaccines during treatment. Blood tests monitor for low white blood cells, anemia, or liver enzyme spikes.[1][3]
Long-Term Risks Patients Report
Users note persistent fatigue, weight gain, hair loss, and skin issues like rashes. Malignancy risk persists post-discontinuation; one study showed 1.5-2 times higher cancer incidence after 5+ years.[2][4]
How Does It Compare to Other JAK Inhibitors?
Xeljanz shares infection and clot risks with Olumiant (baricitinib) and Rinvoq (upadacitinib), but post-marketing data flagged its cardiovascular warnings first in 2021, prompting label updates across the class.[3][5]
[1]: FDA Xeljanz Label - https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203214s029lbl.pdf
[2]: Drugs.com Xeljanz Side Effects - https://www.drugs.com/sfx/xeljanz-side-effects.html
[3]: Xeljanz Safety Study (FDA) - https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death
[4]: Long-term Safety Data (NEJM) - https://www.nejm.org/doi/full/10.1056/NEJMoa2001579
[5]: JAK Inhibitor Comparison (Medscape) - https://www.medscape.com/viewarticle/957057