Ustekinumab-Aekn: uses, dosing, side effects & brands
Ustekinumab-Aekn 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.
Key facts
- Drug class
- Interleukin-12 Antagonist
- Treats
- Ulcerative Colitis, Crohn Disease and Psoriasis
- Available as
- Injectable
- Sold as
- Selarsdi
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How ustekinumab-aekn is dosed
From the FDA label for Selarsdi (application BLA761343). Other ustekinumab-aekn 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) 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) 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 6 years of Age and Older Subcutaneous Recommended Dosage ( 2.2 ): Weight-based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. Weight Range…
Ustekinumab-Aekn 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, induction (≥3%): vomiting. ( 6.1 ) Crohn’s Disease, maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. ( 6.1 ) Ulcerative colitis, induction (≥3%): nasopharyngitis ( 6.1 ) Ulcerative colitis, maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 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…
Who shouldn’t take ustekinumab-aekn
SELARSDI is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in SELARSDI [see Warnings and Precautions ( 5.5 )]. Clinically significant hypersensitivity to ustekinumab products or to any of the excipients in SELARSDI. ( 4 )
Ustekinumab-Aekn drug interactions
7.1 Concomitant Therapies In trials in subjects with plaque psoriasis the safety of ustekinumab products 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 products, antagonists of IL-12 and IL-23, could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of SELARSDI 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 products have not been evaluated in patients who have undergone allergy immunotherapy. Ustekinumab products 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-aekn 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: Selarsdi.
How long ustekinumab-aekn keeps
The date on a sealed pack is not the only one: some ustekinumab-aekn labels start a second clock once the product is opened or mixed, as short as 7 days.
Does ustekinumab-aekn expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about ustekinumab-aekn
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 4 reports naming ustekinumab-aekn, and the FDA flagged 25% 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:
- abdominal discomfort1 reports
- abdominal pain upper1 reports
- alopecia1 reports
- anti-cyclic citrullinated peptide antibody positive1 reports
- arthralgia1 reports
- arthropathy1 reports
- asthenia1 reports
- blood cholesterol increased1 reports
Read these as a signal, not a rate. A report does not mean ustekinumab-aekn 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-aekn?
Selarsdi (Ustekinumab-Aekn) is an interleukin-12 antagonist used to treat Ulcerative Colitis, Crohn Disease, Psoriasis, Psoriatic Arthritis.
What kind of drug is ustekinumab-aekn?
The FDA classifies ustekinumab-aekn 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-aekn 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-aekn 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-aekn come in?
Across the brands we track, ustekinumab-aekn 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-aekn?
We do not currently list a generic-labelled ustekinumab-aekn 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-Aekn: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ustekinumab-aekn
- MLA
- “Ustekinumab-Aekn: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ustekinumab-aekn.
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-aekn on DailyMed (NIH) ↗.