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What are the side effects of stelara?

See the DrugPatentWatch profile for stelara

Common Side Effects of Stelara

Stelara (ustekinumab), used for psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, often causes upper respiratory infections, headaches, and fatigue. Patients report injection-site reactions like redness, itching, or pain in about 4-20% of cases, depending on the condition treated. Nasopharyngitis (cold-like symptoms) affects up to 22% in psoriasis trials.[1]

Serious Side Effects and Risks

Rare but severe risks include serious infections (e.g., tuberculosis reactivation), with rates around 0.2-1% in clinical studies. It increases chances of fungal infections, malignancies (like non-melanoma skin cancer), and hypersensitivity reactions such as anaphylaxis. Reversible posterior leukoencephalopathy syndrome (RPLS) and posterior reversible encephalopathy syndrome (PRES) have been reported, causing neurological symptoms. Long-term use may elevate risks for lymphoma or other cancers.[1][2]

Side Effects by Condition Treated

  • Psoriasis/Psoriatic Arthritis: Most common are respiratory infections (up to 49%), headaches (12%), and pruritus (itching, 11%). Depression occurs in 3-5%.[1]
  • Cro Crohn's/Ulcerative Colitis: Infections rise to 26-41%, with anal abscesses or fistulas in IBD patients (up to 5%). Joint pain and fever are noted in 3-7%.[2]

What Happens During Pregnancy or Breastfeeding?

Stelara crosses the placenta; data from registries show no clear increased birth defect risk, but live vaccines are avoided in exposed infants. It's present in breast milk at low levels—limited data suggest minimal infant exposure. Consult a doctor for personalized risks.[1][2]

Long-Term Side Effects Patients Report

Over years, users note persistent fatigue, joint issues, or new autoimmune flares. Post-marketing reports include psoriasis worsening (paradoxical effect in <1%) and rare cases of Guillain-Barré syndrome. Immunosuppression effects linger months after stopping.[2]

How Does Stelara Compare to Humira or Cosentyx Side Effects?

Stelara has fewer injection reactions than Humira (adalimumab, ~17% vs. 5-10%) but similar infection risks. Versus Cosentyx (secukinumab), it shows lower upper respiratory issues (22% vs. 11%) but comparable serious infection rates (~3%). Cancer signals are similar across IL inhibitors.[1][3]

Sources
[1]: Stelara Prescribing Information (FDA)
[2]: Drugs.com - Stelara Side Effects
[3]: RxList - Stelara vs. Competitors



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