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Stelara

ustekinumab
Used for Plaque Psoriasis, Ulcerative Colitis, Psoriatic Arthritis, Crohn's Disease
Used for Plaque Psoriasis, Ulcerative Colitis, Psoriatic Arthritis, Crohn's Disease

Stelara (ustekinumab) is an injectable medication that belongs to a class called interleukin antagonists. It's used for treating adults and certain children with autoimmune conditions including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. For the most part, Stelara (ustekinumab) is given under the skin either at a clinic or at home. Side effects include inflammation of the nasal passages, headache, and feeling tired.

Reviewed by:
reviewer
Robert Chad Hakim, PharmD, BCCCP
reviewer
Daisy Chau, PharmD
Last reviewed on November 6, 2023
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageInteractionsCostAlternativesLatest newsImagesReferencesPricesMedicare
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What is Stelara (ustekinumab)?

What is Stelara (ustekinumab) used for?

How Stelara (ustekinumab) works

Stelara (ustekinumab) is an interleukin antagonist. It blocks proteins in your immune system called interleukin-12 (IL-12) and interleukin-23 (IL-23) from working. This helps to lower inflammation and treat symptoms caused by autoimmune conditions.

Drug Facts

Common BrandsStelara
Drug ClassIL-12 and IL-23 antagonist
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only

More on Stelara (ustekinumab) essentials

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What are the side effects of Stelara (ustekinumab)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

Plaque psoriasis
  • Inflammation of the nasal passages (7-8%)
  • Upper respiratory tract infection (4-5%)
  • Headache (5%)
Psoriatic arthritis
  • Joint pain (3%)
  • Nausea (3%)
Crohn's disease
  • Inflammation of the nasal passages (11%)
  • Redness at the injection site (5%)
  • Yeast infection (5%)
  • Bronchitis (5%)
Ulcerative colitis:
  • Inflammation of the nasal passages (24%)
  • Headache (10%)
  • Stomach pain (7%)
  • Flu infection (6%)
  • Fever (5%)

Other Side Effects

  • Dizziness
  • Diarrhea
  • Back pain
  • Muscle pain
  • Depression
  • Sore throat
  • Itchiness
  • Vomiting
  • Urinary tract infection

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Serious infection: fever, cough, weight loss, muscle aches, dark urine, chills, vomiting
  • Severe allergic reaction: rash; trouble breathing; swelling of your face, eyes, lips, or mouth; hives
  • Posterior reversible encephalopathy syndrome (PRES): headache, feeling sluggish or confused, vision changes, seizure
  • Swelling in the lungs: trouble breathing, cough

Source: DailyMed

More on Stelara (ustekinumab) side effects

stelara: side effects stelara

9 Stelara Side Effects You Should Know About

Written by Emilie White, PharmD

The following side effects have also been reported

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

chills

cough

cough producing mucus

difficulty with breathing

ear congestion

fever

headache

hoarseness

itching of the vagina or genitals

loss of voice

lower back or side pain

painful or difficult urination

runny or stuffy nose

sneezing

sore throat

stomach pain

thick, white vaginal discharge with mild or no odor

tightness in the chest

unusual tiredness or weakness

Less common

Bladder pain

bloody or cloudy urine

burning feeling while urinating

diarrhea

depression

dizziness

frequent urge to urinate

itching skin

lower back or side pain

pain or tenderness around the eyes and cheekbones

vomiting

Rare

Blurred or loss of vision

clear or bloody discharge from the nipple

confusion

dimpling of the breast skin

disturbed color perception

double vision

halos around lights

inverted nipple

itching, pain, redness, swelling, tenderness, or warmth on the skin

lump in the breast or under the arm

night blindness

overbright appearance of lights

persistent crusting or scaling of the nipple

redness or swelling of the breast

seizures

sore on the skin of the breast that does not heal

tunnel vision

Incidence not known

Chest pain

difficulty with swallowing

dry cough

fast heartbeat

general feeling of tiredness or weakness

hives or welts, skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid breathing

redness of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Muscle aches

Less common

Back pain

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

difficulty with moving

joint pain or swelling

muscle cramps, pain, or stiffness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

pros-and-cons

Pros and cons of Stelara (ustekinumab)

thumbs-up

Pros

Isn't injected as often as other similar medications

Comes as a prefilled syringe for easier home administration

Can be stored at room temperature up to

Can be used in children as young as 6 years old

thumbs-down

Cons

Can weaken your immune system and raise your risk of infection

Potential to cause serious allergic reactions

For CD and UC, the first dose must be given as an IV infusion

Can't receive live vaccines while taking this medication

pharmacist-tips

Pharmacist tips for Stelara (ustekinumab)

pharmacist

  • Mark your injection dates on a calendar. Stelara (ustekinumab) isn't injected that often, so it can be hard to remember when your doses are scheduled.

    • Inject Stelara (ustekinumab) into your stomach area, buttocks, thighs, or outer area of the upper arm. Rotate the site of injection with each dose to avoid any irritation.

      • Let your provider know if you have a latex allergy. The needle cover of the Stelara (ustekinumab) prefilled syringe contains latex.

        • Make sure you know how to properly inject Stelara (ustekinumab). Read the instructions for use to help you. Ask your provider or pharmacist if you have further questions.

          • Because Stelara (ustekinumab) can potentially weaken your immune system, it raises your risk for an infection. Let your provider know right away if you experience symptoms such as fever, chills, muscle aches, diarrhea, or fatigue.

            • Store Stelara (ustekinumab) in its original container in the refrigerator. But it can also be left at room temperature up to 30°C (86°F) for up to 30 days as long as it remains in the original carton. After that, it should be thrown away. Once Stelara (ustekinumab) has warmed up to room temperature, don't put it back in the fridge.

              More on Stelara (ustekinumab) tips

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              faqs

              Frequently asked questions about Stelara (ustekinumab)

              Is Stelara (ustekinumab) a biologic?
              Yes. Stelara (ustekinumab) is considered a biologic medication. Biologic medications are made from living sources, like cells or proteins.
              Is Stelara (ustekinumab) an immunosuppressant?
              Yes, Stelara (ustekinumab) can be considered an immunosuppressant since it can weaken your immune system. This medication works by blocking certain proteins in your immune system, which treats certain autoimmune conditions by lowering inflammation. But doing so also weakens your immune system and can raise your risk for infections.
              Does Stelara (ustekinumab) cause weight gain?
              Stelara (ustekinumab) doesn't appear to cause weight gain. In clinical studies, people taking Stelara (ustekinumab) didn't report weight gain. Speak with your provider if you experience unusual weight changes while you're taking this medication.
              How long can you stay on Stelara (ustekinumab)?
              This will be different for everyone. Keep in mind that Stelara (ustekinumab) doesn't cure certain autoimmune conditions, it only treats the symptoms. While there's no set time limit for how long you can use Stelara (ustekinumab), it's important to have regular discussions with your provider to make sure that this medication is still right for you.
              How long does it take for Stelara (ustekinumab) to work?
              It depends on the condition you're taking Stelara (ustekinumab) for. For example, studies show that some people saw improvement in their symptoms within 3 weeks for Crohn's disease and within 2 weeks for ulcerative colitis. But the full effect for all conditions can take a few months. Keep in mind that everyone responds differently. So make sure to follow up with your provider about how well Stelara (ustekinumab) is working for you.
              Where do you inject Stelara (ustekinumab)?
              Stelara (ustekinumab) is typically given as an injection under the skin into the stomach, buttock, or thigh if you're giving the medication to yourself. It can also be given in the upper back of the arm if another person is giving you the injection. Be sure to choose an injection site that's different from the one you used for the previous dose. And never inject Stelara (ustekinumab) into a muscle or vein.
              Does Stelara (ustekinumab) cause hair loss?
              Hair loss wasn't a reported side effect by people using Stelara (ustekinumab) during clinical trials. Contact your provider if you notice hair loss while you're taking this medication. Your provider can look into possible causes.
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              What are the risks and warnings for Stelara (ustekinumab)?

              Stelara (ustekinumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

              risk-warning

              Infections

              • Risk factors: Active, chronic, or recurrent infection | Taking other medications that weaken your immune system | Having certain conditions that raise risk of infection

                Stelara (ustekinumab) can raise your risk of infections. Serious infections are more common in people taking other immunosuppressant medications and people with certain conditions. Let your provider know your past medical history before starting Stelara (ustekinumab), especially if you've ever had tuberculosis (TB) or certain viral infections. Also tell your provider if you have symptoms of an infection including fever, chills, muscle aches, diarrhea, or feeling very tired. If you develop a serious infection while taking Stelara (ustekinumab) you might have to stop the medication.

                risk-warning

                Cancers

                • Risk factors: Lighter skin color | Older adults | Certain medical conditions | History of skin cancer

                  Stelara (ustekinumab) weakens your immune system and can raise your risk of certain cancers, especially skin cancer. Some cases of skin cancer were seen in people who already had a higher risk of developing skin cancer. Let your provider know if you have a history of skin cancer. Monitor your body for new skin growths and changes to your skin.

                  risk-warning

                  Posterior reversible encephalopathy syndrome (PRES)

                  Posterior reversible encephalopathy syndrome (PRES) is a very rare side effect of Stelara (ustekinumab). Symptoms can appear anytime during treatment, ranging from within a few days and even up to a year or longer after your first dose. Let your provider know if you have any symptoms like headache, confusion, visual changes, and seizures.

                  risk-warning

                  Vaccines

                  You can receive non-live or inactivated vaccines while you're taking Stelara (ustekinumab), but your body might respond differently. Avoid getting live vaccines while you're taking Stelara (ustekinumab). Doing so might cause you to become sick. Make sure your shots are up to date before starting this medication.

                  risk-warning

                  Swelling in the lungs

                  There have been reports of people experiencing swelling in the lungs while taking Stelara (ustekinumab). Symptoms like coughing and trouble breathing were seen after one to three doses of the medication. In some cases, it can become serious and lead to hospitalization. Let your provider know if you're having symptoms so you can be treated right away.

                  dosage

                  Stelara (ustekinumab) dosage forms

                  Typical dosing for Stelara (ustekinumab)

                  Plaque psoriasis

                  • Adults:

                    • Weight 220 lbs or less: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.

                    • Weight more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.

                  • Children ages 6 to under 18 years:

                    • Weight less than 132 lbs: The typical dose is 0.75 mg/kg of body weight injected under the skin once, then another 0.75 mg/kg four weeks later. After the second dose, 0.75 mg/kg is injected every 12 weeks.

                    • Weight of 132 lbs to 220 lbs: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.

                    • Weight more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.

                  Psoriatic arthritis

                  • Adults:

                    • Psoriatic arthritis only: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.

                    • Psoriatic arthritis with plaque psoriasis and weighing more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.

                  • Children ages 6 to under 18 years:

                    • Weight less than 132 lbs: The typical dose is 0.75 mg/kg of body weight injected under the skin once, then another 0.75 mg/kg four weeks later. After the second dose, 0.75 mg/kg is injected every 12 weeks.

                    • Weight of 132 lbs or more: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.

                    • Psoriatic arthritis with plaque psoriasis and weighing more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.

                  Crohn's disease and ulcerative colitis:

                  • Adults: The typical dose is 260 mg to 520 mg infusion into the veins (intravenous, IV) once, then 90 mg under the skin every 8 weeks.

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                  interactions

                  Interactions between Stelara (ustekinumab) and other drugs

                  Stelara (ustekinumab) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Stelara (ustekinumab). Please note that only the generic name of each medication is listed below.

                  More on Stelara (ustekinumab) interactions

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                  Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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                  alternatives

                  What are alternatives to Stelara (ustekinumab)?

                  There are a number of medications that your doctor can prescribe in place of Stelara (ustekinumab). Compare a few possible alternatives below.
                  Stelara (ustekinumab)
                  Used for:
                  $29078.88 Lowest GoodRx priceView Prices
                  Skyrizi (risankizumab)
                  Used for:

                  • Moderate-to-severe plaque psoriasis

                  • Psoriatic arthritis

                  • Moderate-to-severe Crohn's disease

                  $22329.82 Lowest GoodRx priceView Prices
                  Humira (adalimumab)
                  Used for:

                  • Rheumatoid arthritis (RA) - adults only

                  • Juvenile idiopathic arthritis (JIA) - people age 2 and older

                  • Psoriatic arthritis (PsA) - adults only

                  • Ankylosing spondylitis (AS) - adults only

                  • Crohn's disease (CD) - people age 6 and older

                  • Ulcerative colitis (UC) - people age 5 and older

                  • Plaque psoriasis - adults only

                  • Hidradenitis suppurativa (HS) - people age 12 and older

                  • Uveitis - people age 2 and older

                  $1115.35 Lowest GoodRx priceView Prices
                  latest news

                  What is the latest news about Stelara (ustekinumab)?

                  Skyrizi or Stelara — which is right for you? Both are biologic medications that can treat conditions like plaque psoriasis. Compare efficacy, costs, and side effects here.

                  Skyrizi vs. Stelara for Psoriasis: A Complete Guide to Effectiveness, Dosages, Side Effects, and More

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                  Whether you have moderate or severe psoriasis, there are many treatment options. Browse over-the-counter medications, biologics, and more psoriasis treatments.

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                  Biologics are a type of medication that can treat psoriasis, psoriatic arthritis (PsA), and other conditions. Here’s how biologics work for psoriasis and PsA and when they’re used.

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                  Ulcerative colitis (UC) often responds to biologics like Remicade and Humira. Here’s a list of each biologic that treats UC, including side effects and how they work.

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                  Original Medicare, Medicare Advantage plans, and Medicare Part D cover biologics that treat psoriasis and psoriatic arthritis. Learn which psoriasis treatments are covered.

                  What Psoriasis Treatments Does Medicare Cover? Biologics and More

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                  Biosimilars generally cost less than their reference biologics. Here’s how you can find copay assistance and other savings for Humira, Remicade, and Stelara and their biosimilars.

                  How to Save on Biosimilars for Humira, Remicade, and Stelara

                  Biosimilars generally cost less than their reference biologics. Here’s how you can find copay assistance and other savings for Humira, Remicade, and Stelara and their biosimilars.
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                  References

                  Best studies we found

                  Aggeletopoulou, I., et al. (2018). Interleukin 12/interleukin 23 pathway: Biological basis and therapeutic effect in patients with Crohn's disease. World Journal of Gastroenterology.

                  American College of Allergy, Asthma & Immunology. (n.d.). Latex allergy.

                  Feagan, B. G., et al. (2016). Ustekinumab as induction and maintenance therapy for Crohn’s disease. The New England Journal of Medicine.

                  View All References (4)

                  Janssen Biotech, Inc. (2020). Getting comfortable with taking Stelara®.

                  Janssen Biotech, Inc. (2024). Stelara- ustekinumab injection, solution [package insert]. DailyMed.

                  Sands, B. E., et al. (2019). Ustekinumab as induction and maintenance therapy for ulcerative colitis. The New England Journal of Medicine.

                  Sudulagunta, S. R., et al. (2017). Posterior reversible encephalopathy syndrome (PRES). Oxford Medical Case Reports.

                  GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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