Prescription medicine
Ustekinumab Brand names: Wezlana, Pyzchiva, Steqeyma, Yesintek, Starjemza
Ustekinumab (Stelara) is a prescription medicine with an FDA approval on record since 2009. No generic is listed; pharmacies paid $29,874.45 per mL (Stelara 45 mg/0.5 mL syringe) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the ustekinumab FDA label on DailyMed (effective September 8, 2026, Janssen Biotech, Inc.); the BLA 125261 record on Drugs@FDA; every ustekinumab label on DailyMed.
Highlights of the record
FDA label of September 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSTELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy.
Forms and strengths
- 45 mg/.5ml
- 90 mg/ml
- 130 mg/26ml
Injection (solution); solution; injection.
On the market
- Earliest approval on file
- September 25, 2009 Stelara, Centocor Ortho Biotech Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 10 of which 0 under generic applications, 10 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $29,874.45 per mL Stelara 45 mg/0.5 mL syringe
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 102,257 through July 30, 2026
What is ustekinumab used for?
From the label: indications and usageSTELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. ( 1.2 ) Moderately to severely active Crohn's disease in adults and pediatric patients 2 years of age and older. ( 1.3 ) Moderately to severely active ulcerative colitis in adults and pediatric patients 2 years of age and older. […]
Conditions named in the indications of ustekinumab's FDA labels, with every medicine labeled for each:
From other ustekinumab labelsCrohn's disease and ulcerative colitis: Crohn's Disease (CD) PYZCHIVA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease.
FDA pharmacologic class: Interleukin-12 Antagonist and Interleukin-23 Antagonist.
Source: FDA drug label (Stelara), Janssen Biotech, Inc., effective September 8, 2026 (SPL set c77a9664-e3bb-4023-b400-127aa53bca2b), via openFDA; the full label on DailyMed
What does the patient leaflet for ustekinumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about STELARA?STELARA is a medicine that affects your immune system. STELARA can increase your risk of having serious side effects, including: Serious infections. STELARA may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections during treatment with STELARA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection. Your healthcare provider should check you for TB before starting STELARA. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with STELARA and during treatment with STELARA. Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with STELARA. You should not start STELARA if you have any kind of infection unless your healthcare provider says it is okay. Before starting STELARA, tell your healthcare provider if you: think you have an infection or have symptoms of an infection such as: fever, sweat, or chills muscle aches cough shortness of breath blood in phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired are being treated for an infection or have any open cuts. get a lot of infections or have infections that keep coming back. have TB or have been in close contact with someone with TB. After starting STELARA , call your healthcare provider right away if you get any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. […]
From the patient leaflet: What should I avoid while using STELARA?You should avoid receiving a live vaccine during treatment with STELARA. See " Before you use or receive STELARA, tell your healthcare provider about all of your medical conditions, including if you: " What are the possible side effects of STELARA? STELARA may cause serious side effects, including: See " What is the most important information I should know about STELARA? " Serious allergic reactions. Serious allergic reactions including death can occur with STELARA. Stop using STELARA and get medical help right away if you get any of the following symptoms of a serious allergic reaction: feeling faint swelling of your face, eyelids, tongue, or throat chest discomfort trouble breathing skin rash Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a rare condition that affects the brain and can cause death. […]
From the patient leaflet: How should I store STELARA?Store STELARA vials and prefilled syringes in a refrigerator between 36 °F to 46 °F (2 °C to 8 °C). Store STELARA vials standing up straight (upright). Store STELARA in the original carton to protect it from light until time to use it. Do not freeze STELARA. Do not shake STELARA. If needed, individual STELARA prefilled syringes may also be stored at room temperature up to 86 °F (30 °C) for a maximum single period of up to 30 days in the original carton to protect from light. Record the date when the prefilled syringe is first removed from the refrigerator on the carton in the space provided. After a prefilled syringe has been stored at room temperature, do not return it to the refrigerator. Throw away (discard) the prefilled syringe if it is not used within 30 days at room temperature storage. Do not use STELARA after the expiration date on the carton or on the prefilled syringe. […]
Source: FDA drug label (Stelara), Janssen Biotech, Inc., effective September 8, 2026 (SPL set c77a9664-e3bb-4023-b400-127aa53bca2b), via openFDA; the full label on DailyMed
Is there a generic for ustekinumab (Stelara)?
No generic ustekinumab is approved (Drugs@FDA, October 8, 2026).
- 2009 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ustekinumab (Stelara)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $29,874.45 per mL (Stelara 45 mg/0.5 mL syringe), up 5% from $28,422.70 on October 8, 2025. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Stelara 45 mg/0.5 mL syringe | Brand | $29,874.45 per mL | $14,937.22 per single-dose syringe | +5% |
| Stelara 90 mg/mL syringe | Brand | $29,792.79 per mL | n/a | +5% |
| Steqeyma 90 mg/mL syringe | Brand | $3,931.99 per mL | n/a | n/a |
| Yesintek 45 mg/0.5 mL syringe | Brand | $2,855.57 per mL | $1,427.79 per single-dose syringe | n/a |
| Yesintek 90 mg/mL syringe | Brand | $2,902.88 per mL | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the ustekinumab label say about other medicines?
The ustekinumab label names no other medicine on this site. The labels of 3 other medicines name ustekinumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name ustekinumab
Source: FDA drug label (Stelara), Janssen Biotech, Inc., effective September 8, 2026 (SPL set c77a9664-e3bb-4023-b400-127aa53bca2b), via openFDA; the full label on DailyMed
What do FAERS reports show for ustekinumab?
The FDA Adverse Event Reporting System holds 102,257 reports that list ustekinumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,976 are coded as a death and 22,444 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ustekinumab?
4 other medicines are given the same way (subcutaneous) and in the same FDA class as ustekinumab or labeled mainly for the same use (crohn's disease and ulcerative colitis), the same class first. Crohn's disease and ulcerative colitis lists all 29 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ustekinumab-aekn | Crohn's disease and ulcerative colitis | none listed | n/a | No current entry |
| Risankizumab | Crohn's disease and ulcerative colitis | none listed | $22,774.36 per mL 150 mg/mL pen | No current entry |
| Guselkumab | Crohn's disease and ulcerative colitis | none listed | $14,728.91 per mL 100 mg/mL syringe | No current entry |
| Ustekinumab-srlf | Crohn's disease and ulcerative colitis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as ustekinumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ustekinumab compare with medicines for the same use?
2 side-by-side pages set ustekinumab beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ustekinumab
- 4 medicines for the same use
- Other interleukin-12 antagonists
- the pharmacologic class, with prices and generics
- Ustekinumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other