Ustekinumab: uses, dosing, side effects & brands

Ustekinumab is an interleukin-12 antagonist sold in the U.S. under one brand, for ulcerative colitis, crohn disease and psoriasis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Interleukin-12 Antagonist
Treats: Ulcerative Colitis, Crohn Disease and Psoriasis
Available as: Injectable
Sold as: Stelara
Prescription?: Prescription only
Generic available?: Not in our catalog

How ustekinumab is dosed

From the FDA label for Stelara (application BLA761044). Other ustekinumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Adult Patients with Plaque Psoriasis Subcutaneous Recommended Dosage ( 2.1 ) : Weight Range (kilograms) Recommended Dosage less than or equal to 100 kg 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks greater than 100 kg 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Subcutaneous Recommended Dosage ( 2.1 ) : Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. Weight Range (kilograms) Recommended Dose less than 60 kg 0.75 mg/kg 60 kg to 100 kg 45 mg greater than 100 kg 90 mg Psoriatic Arthritis Adult Subcutaneous Recommended Dosage ( 2.2 ) : The recommended dosage is 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks. For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg, the recommended dosage is 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks. Psoriatic Arthritis Pediatric Patients 6 years of Age and Older Subcutaneous Recommended Dosage ( 2.2 ) : Weight-based dosing is recommended at the initial dose, 4 weeks later, then…

Ustekinumab side effects

The following serious adverse reactions are discussed elsewhere in the label: Infections [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.4) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.6) ] Noninfectious Pneumonia [see Warnings and Precautions (5.8) ] Most common adverse reactions are: Psoriasis and Psoriatic Arthritis (≥3%) : nasopharyngitis, upper respiratory tract infection, headache, and fatigue. ( 6.1 ) Crohn's Disease in Adults induction (≥3%): vomiting. ( 6.1 ) maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. ( 6.1 ) Ulcerative Colitis in Adults induction (≥3%): nasopharyngitis. ( 6.1 ) maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect…

Who shouldn’t take ustekinumab

Ustekinumab is contraindicated in patients with clinically significant hypersensitivity to any ustekinumab product or to any of the excipients in Ustekinumab [see Warnings and Precautions (5.5) ]. Clinically significant hypersensitivity to any ustekinumab product or to any of the excipients in Ustekinumab. ( 4 )

Ustekinumab drug interactions

7.1 Concomitant Therapies In trials in subjects with plaque psoriasis the safety of Ustekinumab in combination with immunosuppressive agents or phototherapy has not been evaluated. In trials in subjects with psoriatic arthritis, concomitant MTX use did not appear to influence the safety or efficacy of Ustekinumab. In trials in subjects with Crohn's disease (CD-1 and CD-2) and ulcerative colitis (UC-1), immunomodulators (6-MP, AZA, MTX) were used concomitantly in approximately 30% of subjects and corticosteroids were used concomitantly in approximately 40% and 50% of Crohn's disease and ulcerative colitis subjects, respectively. Use of these concomitant therapies did not appear to influence the overall safety or efficacy of Ustekinumab. 7.2 CYP450 Substrates The formation of CYP450 enzymes can be suppressed by increased levels of certain cytokines (e.g., IL-1, IL-6, TNFα, IFN) during chronic inflammation. Thus, use of Ustekinumab, an antagonist of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of Ustekinumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect or drug concentration and adjust the individual dosage of the CYP substrate as needed. See the prescribing information of specific CYP substrates. A CYP-mediated drug interaction effect was not observed in subjects with Crohn's disease [see Clinical Pharmacology (12.3) ] . 7.3 Allergen Immunotherapy Ustekinumab has not been evaluated in patients who have undergone allergy immunotherapy. Ustekinumab may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.

Every ustekinumab product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Stelara.

How long ustekinumab keeps

The date on a sealed pack is not the only one: some ustekinumab labels start a second clock once the product is opened or mixed, as short as 30 days.

Does ustekinumab expire? The in-use limits and storage rules from its labels

Ustekinumab and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Ustekinumab is usually either not detectable in breastmilk or detectable at very low levels in breastmilk. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Many infants have been safely breastfed during maternal treatment with ustekinumab. Waiting for at least 2 weeks postpartum to resume therapy suspended during pregnancy may minimize transfer to the infant. Numerous experts and professional guidelines have stated that the drug is a low risk to the nursing infant and acceptable to use during breastfeeding.

Full LactMed record for ustekinumab: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised July 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about ustekinumab

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 9,589 reports naming ustekinumab, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

fatigue1,382 reports
drug intolerance1,362 reports
arthralgia1,349 reports
rheumatoid arthritis1,323 reports
rash1,303 reports
treatment failure1,302 reports
synovitis1,301 reports
general physical health deterioration1,273 reports

Read these as a signal, not a rate. A report does not mean ustekinumab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 26, 2026.

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Frequently asked questions

What is ustekinumab?

Stelara (Ustekinumab) is an interleukin-12 antagonist used to treat Ulcerative Colitis, Crohn Disease, Psoriasis, Psoriatic Arthritis.

What kind of drug is ustekinumab?

The FDA classifies ustekinumab as an interleukin-12 antagonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take ustekinumab with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ustekinumab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does ustekinumab come in?

Across the brands we track, ustekinumab is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic ustekinumab?

We do not currently list a generic-labelled ustekinumab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page

APA: pharmaranks. (2026, July 24). Ustekinumab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ustekinumab
MLA: “Ustekinumab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ustekinumab.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for ustekinumab on DailyMed (NIH) ↗.