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What are the side effects of rinvoq for arthritis?

See the DrugPatentWatch profile for rinvoq

Common Side Effects of Rinvoq for Arthritis

Rinvoq (upadacitinib), a JAK inhibitor approved for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, often causes upper respiratory tract infections like colds or sinusitis, affecting about 14-15% of patients. Nausea occurs in around 4-6%, headache in 5-7%, and acne or rash in 3-10%. Elevated liver enzymes (ALT/AST) show up in 4-7%, typically mild and reversible.[1][2]

Serious Side Effects and Risks

Serious risks include infections such as herpes zoster (shingles, 3-4%), pneumonia, or tuberculosis reactivation—patients on Rinvoq have a higher rate than placebo groups. Blood clots (deep vein thrombosis or pulmonary embolism) occurred in 0.3-1% in trials, with a boxed warning for thrombosis, heart attack, stroke, and cancer risk. Gastrointestinal tears or perforations are possible, especially with NSAID use. Low blood cell counts (anemia, lymphopenia) hit 10-20% for some measures. Malignancy risk rose slightly in long-term data.[1][3]

Side Effects in Arthritis Clinical Trials

In SELECT rheumatoid arthritis trials (Phase 3), nasopharyngitis topped lists at 13.7%, followed by elevated creatine kinase (7.3%), bronchitis (6%), and cough (5.3%). For psoriatic arthritis (SELECT-PsA), upper respiratory infections were 20%, with diarrhea at 6%. Ankylosing spondylitis trials (SELECT-AXIS) saw nasopharyngitis at 20.5% and bronchitis at 6.9%. Most resolve without stopping treatment, but monitoring is required.[2][4]

How Side Effects Differ by Arthritis Type

Rinvoq's profile is consistent across types, but infection rates edge higher in rheumatoid arthritis patients on background methotrexate (18% vs. 13% monotherapy). Psoriatic arthritis users report more dermatitis (10%). Long-term extension studies (up to 5 years) show stable rates, with no new signals.[2][4]

What Patients Ask About Managing Side Effects

Doctors screen for infections, TB, and hepatitis before starting, with monthly blood tests initially. Avoid live vaccines. If shingles develops, antivirals help. For clots, discuss risk factors like smoking or immobility. Report fever, persistent cough, or abdominal pain immediately. Weight gain (2-5 kg average) concerns some, linked to fluid retention.[1][3]

Rinvoq vs. Other Arthritis Drugs' Side Effects

Compared to Humira (adalimumab), Rinvoq has fewer injection reactions but higher herpes zoster (3% vs. 1%). Versus Xeljanz (tofacitinib, another JAK inhibitor), rates are similar, though Rinvoq shows slightly less anemia. Steroids carry more osteoporosis risk long-term.[4][5]

[1]: Rinvoq Prescribing Information, AbbVie, https://www.rxabbvie.com/pdf/rinvoqpi.pdf
[2]: FDA Label for Rinvoq, https://www.accessdata.fda.gov/drugsatfda
docs/label/2023/211675s009lbl.pdf
[3]: Rinvoq Safety Profile, Arthritis Foundation, https://www.arthritis.org/drug-guide/jak-inhibitors/rinvoq
[4]: SELECT Clinical Trial Data, New England Journal of Medicine (e.g., SELECT-RA), https://www.nejm.org/doi/full/10.1056/NEJMoa2004450
[5]: Comparative JAK Inhibitor Review, Lancet Rheumatology, https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(21)00002-3/fulltext



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