Ustekinumab Injection
Ustekinumab injection is a biologic medication used to treat moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in eligible adults and children.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Ustekinumab Injection: Patient Information Guide
A plain-language walkthrough of Ustekinumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Ustekinumab injection is a biologic approved to treat several immune-driven inflammatory conditions across different age groups.
- Moderate to severe plaque psoriasis — in adults and children 6 years and older who are candidates for phototherapy or systemic therapy
- Active psoriatic arthritis — in adults and children 6 years and older
- Moderately to severely active Crohn's disease — in adults and children 2 years and older
- Moderately to severely active ulcerative colitis — in adult patients only; not currently approved for children with this condition
⚙️How it works▾
Ustekinumab is a human monoclonal antibody — a highly targeted lab-made protein — that locks onto a specific piece (the p40 subunit) shared by two immune signaling chemicals called IL-12 and IL-23. These cytokines (immune messengers) are involved in activating immune cells that drive chronic inflammation. By blocking IL-12 and IL-23 from connecting to their receptor on immune cell surfaces, ustekinumab interrupts the chain reaction that leads to the skin plaques, joint inflammation, and gut inflammation seen in these conditions.
💊How it's taken▾
How ustekinumab is given depends on the condition being treated. For Crohn's disease and ulcerative colitis, treatment starts with a single IV (intravenous) infusion given in a healthcare setting, then switches to subcutaneous (under-the-skin) injections given every 8 weeks for maintenance. For plaque psoriasis and psoriatic arthritis, it is given as subcutaneous injections at the start, again 4 weeks later, and then every 12 weeks.
- Doses are weight-based — your prescriber calculates the right amount based on your current weight
- In children, a healthcare provider should give the injection; adults may self-inject or have a caregiver inject after proper training
- Rotate the injection site each time; there are no food restrictions with this medication
- If you miss a dose, contact your prescriber for guidance rather than doubling up
🤒Side effects — in detail▾
The most commonly reported side effects vary by condition being treated but generally include:
- Nasopharyngitis (cold-like symptoms — runny nose, sore throat)
- Upper respiratory tract infections
- Headache
- Fatigue
- Injection site redness
- Nausea, vomiting, or diarrhea
- Back pain or dizziness
- Sinusitis or bronchitis (during maintenance treatment for Crohn's disease)
More serious reactions — including severe infections, allergic reactions, a rare brain condition called PRES, non-melanoma skin cancers, and non-infectious pneumonia — have also been reported. Call your doctor right away or seek emergency care if you notice signs of any of these.
⚠️Warnings & precautions▾
- Serious infections: Ustekinumab suppresses immune activity, raising the risk of bacterial, fungal, viral, and mycobacterial infections. Do not start treatment during an active infection. Stop treatment and call your doctor if a serious infection develops.
- Tuberculosis (TB): You must be tested for TB before starting. If you have latent (inactive) TB, it must be treated first. Watch for TB symptoms throughout treatment.
- Cancer risk: As an immunosuppressant, ustekinumab may increase the risk of certain cancers. Rapidly appearing multiple skin cancers (squamous cell carcinomas) have been reported in post-marketing use. Patients over 60 or those with a history of prolonged immunosuppressant therapy or PUVA treatment should be monitored closely.
- Posterior Reversible Encephalopathy Syndrome (PRES): A rare but serious brain condition causing sudden headache, seizures, confusion, or vision changes has been reported. Seek care immediately if these symptoms occur.
- Serious allergic reactions: Anaphylaxis (a life-threatening allergic reaction) and angioedema (severe swelling) have been reported, including during the first IV dose. Get emergency help immediately if you experience difficulty breathing or severe swelling.
- Non-infectious pneumonia: Cases of lung inflammation not caused by infection have occurred. Report new cough, shortness of breath, or breathing difficulty to your doctor promptly.
- Vaccines: Live vaccines must be avoided during treatment. Get all recommended vaccines before starting ustekinumab.
🔀What it interacts with▾
Ustekinumab can interact with certain other treatments and therapies — here are the key ones to know about:
- Live vaccines — must not be given during treatment; they pose an infection risk because ustekinumab suppresses immune function
- BCG vaccine — must be avoided for one year before starting, during treatment, and for one year after stopping
- CYP450-metabolized drugs — ustekinumab may affect how the body processes medications broken down by CYP450 liver enzymes; drugs with a narrow therapeutic index (where small changes in blood level matter a lot) may need monitoring and dose adjustment, especially with Yesintek
- Allergen immunotherapy (allergy shots) — ustekinumab may reduce the protective effect and raise the risk of a severe allergic reaction to allergy shots; use with caution
- Other immunosuppressants — the safety of combining ustekinumab with other immunosuppressants in psoriasis has not been fully studied; your prescriber should weigh the risks
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Active infections: Do not start ustekinumab if you have any clinically significant active infection
- Tuberculosis history: Tell your doctor if you have ever had TB or been exposed to it — testing is required before starting
- History of cancer: Safety in people with a current or prior malignancy has not been established — discuss your history with your prescriber
- Severe allergic reaction to ustekinumab or its ingredients: This is a contraindication — do not use if you have had a clinically significant hypersensitivity reaction to any ustekinumab product
- Latex allergy: The prefilled syringe needle cover contains dry natural rubber (latex) — persons sensitive to latex should not handle it
- Pregnancy: Available data have not identified a clear risk of major birth defects, but discuss the benefits and risks with your doctor; ustekinumab may cross the placenta, especially in the third trimester
- Breastfeeding: Ustekinumab is present in breast milk in small amounts; discuss with your doctor whether to continue breastfeeding
- Children: Not approved for plaque psoriasis or psoriatic arthritis under age 6; not approved for Crohn's disease under age 2; not approved for ulcerative colitis in any pediatric age group
- Older adults (65+): Clinical trials had limited older-adult data; use with awareness that age-related immune changes may affect response or risk
🚑If you take too much▾
In clinical trials, single intravenous doses up to 6 mg/kg were given without dose-limiting toxic effects. If an overdose occurs or is suspected, the patient should be monitored for any signs or symptoms of adverse effects and treated as needed. You can also contact the Poison Help line at 1-800-222-1222 for guidance.
📡Pharmacodynamics — effects in the body▾
In studies of plaque psoriasis, ustekinumab reduced the activity of its targets, IL-12 and IL-23, in skin lesion tissue within two weeks of treatment. In ulcerative colitis clinical trials, higher ustekinumab exposure in the body was associated with better rates of clinical remission, clinical response, and improvement seen on endoscopy (a camera exam of the colon). The benefit appeared to plateau at the exposures achieved with the recommended maintenance dosing schedule.
🔬Pharmacokinetics — how your body processes it▾
When given as a subcutaneous injection for plaque psoriasis, ustekinumab takes about 7 to 13.5 days to reach peak blood levels, depending on the dose. The half-life — the time it takes for the body to clear half the drug — ranges from roughly 15 to 46 days after subcutaneous dosing in psoriasis patients, and is approximately 19 days in people with Crohn's disease or ulcerative colitis. For Crohn's disease and ulcerative colitis, an IV induction dose gives a rapid peak level, and steady maintenance blood levels are reached by the second maintenance subcutaneous dose. The drug is broken down by the body's normal protein-degrading processes (the same way as natural antibodies) and is not processed through the typical liver drug-metabolism pathways; its full metabolic pathway has not been formally characterized.
📦How to store it▾
If necessary, the diluted infusion solution may be kept at room temperature up to 25°C (77°F) for up to 4 hours. time at room temperature begins once the diluted solution has been prepared. and the infusion period).
📄 Written from Ustekinumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Ustekinumab Injection
53 supplements and herbal products have documented interactions with Ustekinumab Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 52
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Ustekinumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What conditions does ustekinumab treat, and is it right for me? ▾
How is ustekinumab given, and will I need to go to a clinic every time? ▾
What side effects should I expect, and which ones should I call my doctor about? ▾
Do I need to worry about getting my vaccines while on ustekinumab? ▾
Is ustekinumab safe during pregnancy or while breastfeeding? ▾
Can ustekinumab interact with my other medications? ▾
Is Ustekinumab Injection available over the counter? ▾
When was Ustekinumab Injection first available? ▾
Who makes Ustekinumab Injection? ▾
💬 Answers drafted from Ustekinumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Ustekinumab Injection comes
Ustekinumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Treats moderate to severe plaque psoriasis in adults and children 6 years and older who are candidates for phototherapy or systemic therapy
- Treats active psoriatic arthritis in adults and children 6 years and older
- Treats moderately to severely active Crohn's disease in adults and children 2 years and older
- Treats moderately to severely active ulcerative colitis in adults only
- For Crohn's disease and ulcerative colitis: treatment begins with a single intravenous infusion given by a healthcare provider, followed by subcutaneous maintenance injections every 8 weeks starting at Week 8
- For plaque psoriasis and psoriatic arthritis: given as subcutaneous injections at the start, 4 weeks later, then every 12 weeks; dosing is weight-based
- Yesintek: when starting or stopping in patients also taking medications processed by CYP450 enzymes with a narrow therapeutic index, those drug levels may need to be monitored and adjusted
- Subcutaneous injections should be rotated to a different site each time; in pediatric patients, a healthcare provider should administer the injection unless a caregiver has been properly trained
📊 Ustekinumab Injection across the U.S. market
How Ustekinumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Ustekinumab Injection is used
A general measure of how commonly Ustekinumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ustekinumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ustekinumab Injection prescribed? Of the 1,597 medications we measure, Ustekinumab Injection ranks #611 by Medicaid prescriptions — more than 62% of them.
Utilization by Ustekinumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1 ML ustekinumab 90 MG/ML Prefilled Syringe Most dispensed
Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 853355
0.5 ML ustekinumab 90 MG/ML Prefilled Syringe
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 853350
0.5 ML ustekinumab 90 MG/ML Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1654077
1 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2705400
26 ML ustekinumab 5 MG/ML Injection
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1811255
1 ML ustekinumab-ttwe 90 MG/ML Prefilled Syringe
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2705575
1 ML ustekinumab-stba 90 MG/ML Prefilled Syringe
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2700411
0.5 ML ustekinumab-aekn 90 MG/ML Prefilled Syringe
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2705393
1 ML ustekinumab-aauz 90 MG/ML Prefilled Syringe
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2702606
0.5 ML ustekinumab-ttwe 90 MG/ML Prefilled Syringe
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2705568
26 ML ustekinumab-aekn 5 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2705382
0.5 ML ustekinumab-stba 90 MG/ML Prefilled Syringe
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2700404
Other Ustekinumab Injection products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 2 of 11 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ustekinumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 15 of 40 listed Ustekinumab Injection NDCs with Medicaid activity.
🔍 Compare Ustekinumab Injection products
A representative set of FDA-listed product records for Ustekinumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 45 mg/0.5 mL | Subcutaneous | Biocon Biologics Inc. × 8 listings | BLA | View NDC → |
| 90 mg/mL | Subcutaneous | Biocon Biologics Inc. × 4 listings | BLA | View NDC → |
| 130 mg/26 mL | Intravenous | Biocon Biologics Inc. × 4 listings | BLA | View NDC → |
| 5 mg/mL | — | BioConnection B.V. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 45 mg/0.5 mL | Subcutaneous | Janssen Biotech, Inc. × 8 listings | BLA | View NDC → |
| 90 mg/mL | Subcutaneous | Janssen Biotech, Inc. × 8 listings | BLA | View NDC → |
| 130 mg/26 mL | Intravenous | Janssen Biotech, Inc. × 8 listings | BLA | View NDC → |
| 1 mg/mg | — | Janssen Pharmaceutical Sciences Unlimited Company | BULK INGREDIENT | View NDC → |
Showing 42 of 42 products — FDA National Drug Code Directory. See every product, package size and price: browse all 42 Ustekinumab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ustekinumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ustekinumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Ustekinumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 847083 3 dose forms · 37 strengths
-
Dose form (SCDF) Auto-Injector RxCUI 2720510In current FDA listingsClinical drug / strength (SCD) 0.5 ML ustekinumab-ttwe 90 MG/MLRxCUI 27205121 ML ustekinumab-ttwe 90 MG/MLRxCUI 2721430 -
Dose form (SCDF) Injection RxCUI 1654076In current FDA listingsClinical drug / strength (SCD) 0.5 ML ustekinumab 90 MG/MLRxCUI 16540770.5 ML ustekinumab-aauz 90 MG/MLRxCUI 27244290.5 ML ustekinumab-aekn 90 MG/MLRxCUI 27261160.5 ML ustekinumab-auub 90 MG/MLRxCUI 27006790.5 ML ustekinumab-hmny 90 MG/MLRxCUI 27251020.5 ML ustekinumab-kfce 90 MG/MLRxCUI 27056010.5 ML ustekinumab-stba 90 MG/MLRxCUI 27407980.5 ML ustekinumab-ttwe 90 MG/MLRxCUI 271388526 ML ustekinumab 5 MG/MLRxCUI 181125526 ML ustekinumab-aauz 5 MG/MLRxCUI 270261926 ML ustekinumab-aekn 5 MG/MLRxCUI 270538226 ML ustekinumab-auub 5 MG/MLRxCUI 270066926 ML ustekinumab-hmny 5 MG/MLRxCUI 272511126 ML ustekinumab-kfce 5 MG/MLRxCUI 270558126 ML ustekinumab-srlf 5 MG/MLRxCUI 271706726 ML ustekinumab-stba 5 MG/MLRxCUI 270039326 ML ustekinumab-ttwe 5 MG/MLRxCUI 2705557 -
Dose form (SCDF) Prefilled Syringe RxCUI 853349No current FDA listingClinical drug / strength (SCD) 0.5 ML ustekinumab 90 MG/MLRxCUI 8533500.5 ML ustekinumab-aauz 90 MG/MLRxCUI 27026150.5 ML ustekinumab-aekn 90 MG/MLRxCUI 27053930.5 ML ustekinumab-auub 90 MG/MLRxCUI 27006850.5 ML ustekinumab-hmny 90 MG/MLRxCUI 27250870.5 ML ustekinumab-kfce 90 MG/MLRxCUI 27055920.5 ML ustekinumab-srlf 90 MG/MLRxCUI 27170780.5 ML ustekinumab-stba 90 MG/MLRxCUI 27004040.5 ML ustekinumab-ttwe 90 MG/MLRxCUI 27055681 ML ustekinumab 90 MG/MLRxCUI 8533551 ML ustekinumab-aauz 90 MG/MLRxCUI 27026061 ML ustekinumab-aekn 90 MG/MLRxCUI 27054001 ML ustekinumab-auub 90 MG/MLRxCUI 27006911 ML ustekinumab-hmny 90 MG/MLRxCUI 27250991 ML ustekinumab-kfce 90 MG/MLRxCUI 27055991 ML ustekinumab-srlf 90 MG/MLRxCUI 27170851 ML ustekinumab-stba 90 MG/MLRxCUI 27004111 ML ustekinumab-ttwe 90 MG/MLRxCUI 2705575
Look up RxCUI 847083 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Ustekinumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Ustekinumab Injection belongs to the Interleukin-12 Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 3 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Janssen Biotech, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.