FDA label

What is Stelara used for?

Stelara contains ustekinumab. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.

Source: DailyMed SPL label file dated 2026-10-23. Publisher page

The FDA label for Stelara lists 4 uses: Plaque Psoriasis (PsO); Psoriatic Arthritis (PsA); Crohn's Disease (CD); Ulcerative Colitis (UC).

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Stelara, injection, solution

Indications and Usage, quoted from the label by Janssen Biotech, Inc. (BLA125261). Cross-references to other label sections are left out.

Plaque Psoriasis (PsO)

STELARA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Psoriatic Arthritis (PsA)

STELARA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis.

Crohn's Disease (CD)

STELARA is indicated for the treatment of adults and pediatric patients 2 years of age and older with moderately to severely active Crohn's disease.

Ulcerative Colitis (UC)

STELARA is indicated for the treatment of adults and pediatric patients 2 years of age and older with moderately to severely active ulcerative colitis.

Source: DailyMed label, set id c77a9664-e3bb-4023-b400-127aa53bca2b, version 49, effective September 8, 2026. NDC 57894-060, one of 2 listings for this product.

Questions

What is Stelara used for?

The FDA label for Stelara lists 4 uses: Plaque Psoriasis (PsO); Psoriatic Arthritis (PsA); Crohn's Disease (CD); Ulcerative Colitis (UC).

What drug class is Stelara?

FDA lists ustekinumab in the Interleukin-12 Antagonist and Interleukin-23 Antagonist established pharmacologic class.

Does this page cover off-label uses or dosing?

No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.

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