Prescription medication · Anti-IL-12/23 Monoclonal Antibody
ustekinumab
Also sold as Stelara. This medicine can treat moderate to severe plaque psoriasis in adults and children 6 years and older.
Data updated 2026-05-15
- 98,899
- FDA reportsOften reported
- $26794.63
- Brand price (NADAC)
ustekinumab (Stelara) is a prescription Anti-IL-12/23 Monoclonal Antibody. This medicine can treat moderate to severe plaque psoriasis in adults and children 6 years and older.
Ustekinumab-aekn (Stelara) is a medicine that helps control inflammation in your body. It works by blocking certain proteins that cause inflammation.
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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.
The sections below are summarized in plain English from ustekinumab's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of ustekinumab's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of ustekinumab's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. Then, continue with your regular schedule.
This is a plain-language summary of ustekinumab's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
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 98,899 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for ustekinumab, by number of reports
- Tiredness
Tiredness
6,589 reports
- Psoriasis
Psoriasis
6,432 reports
- Pain
Pain
6,034 reports
- Joint pain
Joint pain
5,628 reports
- Crohn's disease
Crohn's disease
5,563 reports
- Skin rash
Skin rash
5,438 reports
- Headache
Headache
5,130 reports
- Condition is getting worse
Condition is getting worse
5,056 reports
- Reaction to the medicine given through a vein
Reaction to the medicine given through a vein
4,945 reports
- Rheumatoid arthritis
Rheumatoid arthritis
4,644 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for ustekinumab each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where ustekinumab sits
ustekinumab has more FDA adverse-event reports than 85% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is ustekinumab; the line is the median (50th percentile).
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
Reports Mentioning Death
5,465
5.5% of reports — not proof of cause
Hospitalization Reports
21,428
Top Indication
Psoriasis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 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 |
| 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 |
| 16 | HYPERSENSITIVITY | 4,467 |
| 17 | DIARRHOEA | 4,464 |
| 18 | SYNOVITIS | 4,423 |
| 19 | ALOPECIA | 4,408 |
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?
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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 98,899 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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