ustekinumab
Brand names: Stelara
Ustekinumab-aekn (Stelara) is a medicine that helps control inflammation in your body. It works by blocking certain proteins that cause inflammation.
Drug Pricing (NADAC)
Brand Price
$26794.63/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine can treat moderate to severe plaque psoriasis in adults and children 6 years and older.
Common side effects
Common cold symptoms (nasopharyngitis), Upper respiratory infection, Headache
Key warnings
Ustekinumab-aekn can increase your risk of getting serious infections.
How It Works
Ustekinumab-aekn blocks two proteins in your body called interleukin-12 and interleukin-23. These proteins cause inflammation. By blocking them, the medicine helps reduce inflammation and the symptoms of your condition.
How to Take It
This medicine is given as an injection under your skin or through a vein. For psoriasis and psoriatic arthritis, adults usually get a 45 mg or 90 mg injection initially, then again 4 weeks later. After that, you'll get an injection every 12 weeks. For Crohn's disease and ulcerative colitis, you will get a single intravenous infusion based on your weight, followed by a 90 mg injection under your skin 8 weeks later, then every 8 weeks.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if ustekinumab-aekn will harm your unborn baby. Talk to your doctor about the risks and benefits of using this medicine during pregnancy. It is also not known if ustekinumab-aekn passes into breast milk.
Missed Dose
If you miss a dose, take it as soon as you remember. Then, continue with your regular schedule.
Storage
Store Ustekinumab-aekn in the refrigerator between 36°F to 46°F (2°C to 8°C) in its original carton to protect it from light. Do not freeze or shake.
Side Effects (from patient reports)
Based on 77,446 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 98,899 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2009–2025.
Total Reports
98,899
Death-Related Reports
5,465
Hospitalization Reports
21,428
Top Indication
Psoriasis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 14,436 |
| 2 | OFF LABEL USE | 12,254 |
| 3 | PRODUCT DOSE OMISSION ISSUE | 9,763 |
| 4 | FATIGUE | 6,589 |
| 5 | PSORIASIS | 6,433 |
| 6 | PAIN | 6,033 |
| 7 | ARTHRALGIA | 5,628 |
| 8 | CROHN^S DISEASE | 5,563 |
| 9 | RASH | 5,437 |
| 10 | PRODUCT USE ISSUE | 5,310 |
| 11 | HEADACHE | 5,129 |
| 12 | CONDITION AGGRAVATED | 5,057 |
| 13 | INFUSION RELATED REACTION | 4,945 |
| 14 | RHEUMATOID ARTHRITIS | 4,644 |
| 15 | JOINT SWELLING | 4,567 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Ustekinumab-aekn can increase your risk of getting serious infections. Tell your doctor if you have any signs of an infection, like fever, cough, or body aches. Before starting this medicine, your doctor should check you for tuberculosis (TB). This medicine may also increase your risk of certain cancers. Contact your doctor right away if you have a severe allergic reaction. This medicine can also cause a rare condition called Posterior Reversible Encephalopathy Syndrome (PRES).
Common Questions
Can I get vaccines while taking Ustekinumab-aekn?
What should I do if I think I have an infection?
Can Ustekinumab-aekn cause allergic reactions?
Does Ustekinumab-aekn interact with other medicines?
Can I store Ustekinumab-aekn at room temperature?
What does Ustekinumab-aekn look like?
What should I do if I experience side effects?
Will Ustekinumab-aekn cure my condition?
How long does it take for Ustekinumab-aekn to start working?
Can I take Ustekinumab-aekn if I have cancer?
What are the common side effects of ustekinumab?
What drug class is ustekinumab?
Is ustekinumab safe during pregnancy?
Related Medications in Anti-IL-12/23 Monoclonal Antibody
Other drugs grouped near ustekinumab — same-class peers and common alternatives.
adapalene
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apremilast
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azelaic acid
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benzoyl peroxide
Benzac, PanOxyl
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betamethasone
Diprosone, Luxiq
Betamethasone dipropionate cream is a strong steroid medicine used on the skin.
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What the FDA Data Shows for ustekinumab
The FDA label for ustekinumab (sold under brand names such as Stelara) classifies it as a prescription-only medication in the Anti-IL-12/23 Monoclonal Antibody class. This medicine can treat moderate to severe plaque psoriasis in adults and children 6 years and older. Official labeling lists 16 commonly reported side effects, including Common cold symptoms (nasopharyngitis), Upper respiratory infection, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 77,446 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 5, 2026
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages