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Does Stelara cause weight gain?

Medically reviewed by Kristianne Hannemann, PharmD. Last updated on March 31, 2025.

Official answer

by Drugs.com

Weight gain was not reported as a common side effect of Stelara (ustekinumab) in clinical trials. However, post-approval studies examining its impact on weight have shown mixed results.

Is There Evidence That Stelara Causes Weight Gain?

Several studies have explored whether Stelara contributes to weight gain in patients with various conditions:

  • Inflammatory Bowel Disease (IBD): A small study found that individuals taking Stelara for IBD gained approximately 4 kg (8.8 lbs) over 12 months, with continued weight gain reaching 6.1 kg (13.4 lbs) at 24 months.
  • Another IBD study observed moderate weight gain in patients taking Stelara, reporting an increase of 1.2 kg (2.6 lbs) at week 30 and 2.3 kg (5 lbs) at week 54.
  • Plaque Psoriasis: A 7-month study on individuals with plaque psoriasis found no significant changes in body mass index (BMI).
  • A separate small study showed that 7 out of 11 patients with plaque psoriasis gained around 2.3 kg (5 lbs) after 28 weeks of treatment.

Related questions

Why Might Stelara Cause Weight Gain?

The exact reason why some patients experience weight gain while taking Stelara is unclear. Researchers speculate that Stelara’s mechanism of action—blocking inflammatory cytokines—may influence metabolism, which could contribute to weight changes. However, more research is needed to confirm this connection.

If you notice significant changes in your weight while taking Stelara, whether gain or loss, consult your healthcare provider. They can help assess whether the medication or another factor may be responsible and provide guidance on managing weight-related concerns.

This is not all the information you need to know about Stelara (ustekinumab) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

References

Borren, N. Z., et. al. 2020. Assessment of Body Weight Changes in Patients with Inflammatory Bowel Diseases Initiating Biologic Therapy: A Prospective Cohort Study. In: Digestive Diseases and Sciences. DOI: https://doi.org/10.1007/s10620-020-06442-9

Gisondi, P., et. al. 2013. Ustekinumab does not increase body mass index in patients with chronic plaque psoriasis: a prospective cohort study. In: Oxford Academy. DOI: https://doi.org/10.1111/bjd.12235

Owczarczyk-Saczonek, A. Influence of ustekinumab on body weight of patients with psoriasis: an initial report. In: Advances in Dermatology and Allergology. DOI: https://doi.org/10.5114%2Fpdia.2014.40656

Stelara [package insert]. Updated March 2024. Janssen Biotech, Inc. Accessed September 25, 2024 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b

Stewart, O., et. al. 2021. A Comparison of Weight Gain in Patients With Inflammatory Bowel Disease Treated With TNF-alpha Inhibitors, Vedolizumab or Ustekinumab. In: The American Journal of Gastroenterology. DOI: https://doi.org/10.14309/01.ajg.0000776964.51447.96

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Does Stelara treat ulcerative colitis?

Yes, Stelara was approved by the FDA on October 21, 2019 for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). UC is a serious and long-term inflammatory disease that affects the large intestine (colon) and rectum. Stelara works by targeting proteins called interleukins (IL)-12 and IL-23 to lower inflammation, a main feature of ulcerative colitis. Continue reading

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