Key takeaways

  • Stelara (ustekinumab) is a brand-name biologic drug used for certain autoimmune conditions. It works by reducing immune system activity, which can help reduce inflammation and other symptoms.
  • Stelara’s side effects can range from mild issues like headaches and upper respiratory infections to more serious ones. Severe infections and allergic reactions are some possible serious side effects.
  • You’ll receive Stelara as a subcutaneous injection. For Crohn’s disease and ulcerative colitis, the first dose is given as an IV infusion (an injection into your vein that’s given over a period of time).

Stelara is approved by the Food and Drug Administration (FDA) to treat:

Drug details

You’ll find key information about Stelara here.

Stelara is a brand-name biologic drug that contains the active ingredient ustekinumab. It’s also available in biosimilar forms:

  • Imuldosa (ustekinumab-srlf)
  • Otulfi (ustekinumab-aauz)
  • Selarsdi (ustekinumab-aekn)
  • Starjemza (ustekinumab-hmny)
  • Steqeyma (ustekinumab-stba)
  • Pyzchiva (ustekinumab-ttwe)
  • Wezlana (ustekinumab-auub)
  • Yesintek (ustekinumab-kfce)

A biosimilar is a medication that’s similar to a brand-name biologic medication (the parent drug). Biologics are made from living cells. It’s not possible to make an exact copy of a biologic. A generic, on the other hand, refers to medications made from chemicals. A generic is an exact copy of the active medication in a brand-name medication.

Biosimilars are considered to be just as safe and effective as their parent drug. And like generics, biosimilars tend to cost less than brand-name medications.

Note: The suffixes at the end of each biosimilar active ingredient are to show that these are distinct forms of ustekinumab.

Stelara can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while using Stelara. These lists do not include all possible side effects.

For more information on the possible side effects of Stelara, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be concerning or bothersome.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect while using Stelara and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

More common side effects

The more common side effects of Stelara can include:

For more information about some of these side effects, see the “Side effect details” section.

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Stelara aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

  • Severe bacterial, fungal, or viral infections. Examples of infections that can occur include:
  • Posterior reversible leukoencephalopathy syndrome (swelling in your brain). Symptoms can include:
    • headache
    • confusion
    • seizures
    • vision changes
  • Lung problems caused by inflammation, such as certain types of pneumonia not related to infection. Symptoms can include:
    • dry cough that doesn’t go away
    • shortness of breath
    • respiratory failure (weak and shallow breathing)
  • Possible increased risk of cancer. Symptoms can include:
    • cough
    • unexplained weight loss
    • fatigue
    • skin changes
  • Severe allergic reaction. For more information, see the “Side effect details” section.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on some of the side effects this drug may or may not cause.

Headache

You may experience headaches while using Stelara. Headaches were one of the most common side effects reported during clinical trials.

If you have headaches while using Stelara, talk with your doctor about using over-the-counter medications to help relieve your symptoms.

Depression

Depression is a possible side effect of Stelara.

People with autoimmune diseases, such as Crohn’s disease or psoriasis, may have a higher risk of depression. It’s thought that the stress of having a chronic (long-term) autoimmune disease can lead to depression in some people.

If you feel depressed while using Stelara, talk with your doctor about ways to help manage your mood.

Diarrhea

In clinical studies of people with plaque psoriasis, diarrhea was reported. This wasn’t a commonly reported side effect in people using Stelara for psoriatic arthritis or Crohn’s disease, however.

If you have diarrhea while using Stelara, talk with your doctor about ways to reduce this side effect.

Colds

You may have more frequent colds or upper respiratory infections while using Stelara. Colds may occur because Stelara decreases your immune system’s ability to fight off infections.

If you have frequent colds while using Stelara, talk with your doctor about ways to treat your symptoms.

Allergic reaction

For some people, Stelara can cause an allergic reaction. In general, symptoms of an allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Stelara, your doctor may recommend a different medication instead.

Side effects in children

In children using Stelara for plaque psoriasis or psoriatic arthritis, side effects are expected to be similar to side effects seen in adults.

The Food and Drug Administration (FDA) approves prescription drugs such as Stelara to treat certain conditions. Stelara may also be used off-label for other conditions. (Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition.)

Stelara for plaque psoriasis

Stelara is FDA approved to treat moderate to severe plaque psoriasis in adults and children ages 6 years and older. It’s approved for use in people who could receive treatment with either:

  • systemic therapy (drugs that affect the entire body, which can be taken by mouth or through an injection),
  • or phototherapy (light therapy)

Plaque psoriasis is an autoimmune disease that causes plaques on your skin. Plaques are areas on your skin that are raised and may be red- or silver-colored. They may also feel itchy.

In clinical studies, Stelara was effective in treating adults and adolescents with moderate to severe plaque psoriasis. You can refer to the drug’s prescribing information for details.

Stelara for psoriatic arthritis

Stelara is FDA approved to treat psoriatic arthritis in adults and children ages 6 years and older. Psoriatic arthritis is a condition that causes patches of psoriasis on your skin and arthritis in your joints.

For psoriatic arthritis, your doctor might prescribe Stelara alone or in combination with methotrexate (Otrexup, Rasuvo, Trexall, others). Your doctor will discuss whether the combination of Stelara and methotrexate is right for you.

In clinical studies, Stelara was effective at reducing psoriatic arthritis symptoms in adults and children. You can refer to the drug’s prescribing information for details.

Stelara for Crohn’s disease

Stelara is FDA approved to treat moderate to severe Crohn’s disease in adults.

Crohn’s disease is a type of inflammatory bowel disease. It causes inflammation in your gastrointestinal (GI) tract. With Crohn’s disease, you may have:

  • diarrhea
  • blood in your stools
  • pain and cramps in your abdomen

In a clinical study, Stelara was found to be effective at helping people with Crohn’s disease reach remission (a state of having very few or no symptoms). You can refer to the drug’s prescribing information for details.

Stelara for ulcerative colitis

Stelara is FDA approved to treat moderate to severe ulcerative colitis in adults.

This condition is a type of inflammatory bowel disease. It causes inflammation in your GI tract.

With ulcerative colitis, you may have:

  • abdominal pain
  • bloody diarrhea

In clinical studies, Stelara was effective in treating ulcerative colitis in adults. To learn how the drug performed in these studies, see the drug’s prescribing information.

Additionally, guidelines from the American Gastroenterological Association suggest Stelara as a treatment option for adults with moderate to severe ulcerative colitis.

Stelara and children

Stelara is FDA approved for use in children ages 6 and older with moderate to severe plaque psoriasis or psoriatic arthritis. See the “Stelara for plaque psoriasis” and “Stelara for psoriatic arthritis” sections for more details.

As with all medications, the cost of Stelara can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance: If you need financial support to pay for Stelara, or if you need help understanding your insurance coverage, help is available.

Stelara’s manufacturer offers a program called Janssen CarePath. For more information and to find out if you’re eligible for support, call 877-CAREPATH (877-227-3728) or visit the program website.

Generic or biosimilar versions: Stelara is a brand-name biologic drug that’s also available as the following biosimilar drugs: Imuldosa, Otulfi, Selarsdi, Starjemza, Steqeyma, Pyzchiva, Wezlana, and Yesintek.

A biosimilar is a medication that’s similar to a brand-name biologic medication (the parent drug). Biosimilars are considered to be just as safe and effective as their parent drug. And like generics, biosimilars tend to cost less than brand-name medications. (See the “Stelara generic or biosimilar” section for details.)

To find out how the cost of these biosimilars compares to the cost of Stelara, talk with your doctor or pharmacist.

The conditions that Stelara is approved to treat are partly caused by an overactive immune system. With an overactive immune system, your body mistakes healthy cells for foreign invader cells, such as germs. This can cause symptoms such as skin plaques, joint pain, or inflammation in your intestines.

Stelara helps decrease your immune system activity by attaching to specific proteins, called interleukin-12 (IL-12) and interleukin-23 (IL-23). This is Stelara’s mechanism of action. These proteins cause inflammation in your body. They also activate other immune system cells, which can worsen symptoms of your condition.

When Stelara attaches to IL-12 and IL-23, it blocks them from causing inflammation and from turning on other immune system cells. This results in less inflammation, fewer symptoms, and improvement in your condition.

How long does it take Stelara to work?

Stelara starts working shortly after you take a dose. However, it could be several weeks before you start to notice that your symptoms have eased.

The Stelara dosage your doctor prescribes will depend on several factors. These include:

  • the condition, or conditions, you’re using Stelara to treat
  • your age
  • your weight

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Stelara comes as a liquid solution that’s given by subcutaneous injection in your upper arm, thigh, abdomen, or buttocks. Your healthcare professional may give you Stelara injections at a medical clinic. They may also show you or a caregiver how to inject Stelara at home.

Stelara is available in the following forms and strengths:

  • a single-dose prefilled syringe that holds 0.5 milliliters (mL) of solution and contains 45 milligrams (mg) of ustekinumab
  • a single-dose prefilled syringe that holds 1 mL of solution and contains 90 mg of ustekinumab
  • a single-dose vial that holds 0.5 mL of solution and contains 45 mg of ustekinumab

Note: In people with Crohn’s disease or ulcerative colitis, a one-time IV infusion of Stelara is given as a “loading dose” or an “induction dose” when you start treatment. An infusion is an injection into your vein that’s given over a period of time. Stelara infusions take at least 1 hour. Each dose of Stelara after the IV infusion is given as a subcutaneous injection. This infusion helps deliver a large starting dose of the medication, so it starts working right away.

Dosage for plaque psoriasis

Stelara is approved to treat plaque psoriasis in both adults and children ages 6 years and older. The typical dosage for adults is described here. (The children’s dosage is described below under “Pediatric dosage.”)

Stelara is given as one subcutaneous injection on each of the following days:

  • your first dose is given on day 1
  • your second dose is given 4 weeks later
  • your third dose is given 12 weeks after your second dose
  • the rest of your doses are given every 12 weeks

The usual dosage of Stelara for plaque psoriasis is based on your body weight and age. In adults with plaque psoriasis, the typical dosage of Stelara for each injection is as follows:

  • for adults who weigh 100 kilograms (kg) (about 220 pounds [lb]) or less, their usual dose is 45 mg
  • for adults who weigh more than 100 kg, their usual dose is 90 mg

Dosage for psoriatic arthritis

The usual dosage of Stelara for psoriatic arthritis in adults is 45 mg for each injection. (The children’s dosage is described below under “Pediatric dosage.”)

Stelara is given as one subcutaneous injection on each of the following days:

  • your first dose is given on day 1
  • your second dose is given 4 weeks later
  • your third dose is given 12 weeks after your second dose
  • the rest of your doses are given every 12 weeks

The recommended dose is 45 mg. If you weigh more than 100 kg (about 220 lb) and you have psoriatic arthritis with plaque psoriasis, your doctor may prescribe a 90-mg dose of Stelara for you.

Dosage for Crohn’s disease

The usual dosage of Stelara for adults with Crohn’s disease is 90 mg given once every 8 weeks via subcutaneous injection. When treating Crohn’s disease, this is called your maintenance dosage.

However, the first dose of Stelara that you’ll receive is called an induction dose or loading dose. It’s given as an IV infusion.

The usual dosage for the loading dose is based on your body weight in kilograms (kg), as follows:

  • for adults who weigh 55 kg (about 121 lb) or less, the loading dose is 260 mg
  • for adults who weigh between 55 kg and 85 kg (about 187 lb), the loading dose is 390 mg
  • for adults who weigh more than 85 kg, the loading dose is 520 mg

Every dose of Stelara that you receive after your loading dose will be given via subcutaneous injection.

Dosage for ulcerative colitis

The usual dosage of Stelara for adults with ulcerative colitis is 90 mg given once every 8 weeks via subcutaneous injection. When treating ulcerative colitis, this is called your maintenance dosage.

However, the first dose of Stelara that you’ll receive is called an induction dose or loading dose. It’s given as an IV infusion.

The usual dosage for the loading dose is based on your body weight, as follows:

  • for adults who weigh 55 kg (about 121 lb) or less, the loading dose is 260 mg
  • for adults who weigh between 55 kg and 85 kg (about 187 lb), the loading dose is 390 mg
  • for adults who weigh more than 85 kg, the loading dose is 520 mg

Every dose of Stelara that you receive after your loading dose will be given via subcutaneous injection.

Children’s dosage

Stelara is approved to treat plaque psoriasis and psoriatic arthritis in both adults and children ages 6 years and older. The typical dosages for children are described here.

Stelara is given as one subcutaneous injection on each of the following days:

  • the first dose is given on day 1
  • the second dose is given 4 weeks later
  • the third dose is given 12 weeks after the second dose
  • the following doses are given every 12 weeks

Stelara’s dosing in children is based on body weight. In children with plaque psoriasis or psoriatic arthritis, the typical dosage of Stelara for each injection is as follows:

  • for those who weigh less than 60 kg (about 132 lb), the usual dosage is 0.75 mg of drug per kg of body weight
  • for those who weigh between 60 kg and 100 kg (about 220 lb), their usual dosage is 45 mg
  • for those who weigh more than 100 kg, their usual dosage is 90 mg

What if I miss a dose?

It’s important to keep your appointments with your healthcare professional for Stelara injections. If you miss an appointment, call your clinic right away. They can reschedule your appointment.

If you’re using Stelara at home and you miss a dose, inject it as soon as you remember. Do not inject more than one dose at a time. This can increase your risk of serious side effects.

Talk with your doctor about any missed doses. They can help you adjust the timing of your doses, if needed.

Will I need to use Stelara long term?

Stelara is meant to be used as a long-term treatment. How long you can stay on Stelara depends on how long you and your doctor determine that the drug is safe and effective for you.

Optum Now is operated by RVO Health. By clicking on this link, we may receive a commission. Learn more.

You may wonder how Stelara compares with other medications that are prescribed for similar uses. See the following sections for some comparisons.

Stelara vs. Skyrizi

Skyrizi and Stelara are approved for treating the same conditions in adults: plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Skyrizi is not approved for use in children, but Stelara can be used in children 6 years and older with plaque psoriasis or psoriatic arthritis.

Stelara’s active ingredient is ustekinumab. Skyrizi’s active ingredient is risankizumab-rzaa. Both are biologic drugs (drugs made from living cells). Both drugs are given by subcutaneous injection and by IV infusion for the first dose of Crohn’s disease and ulcerative colitis treatment.

Your doctor or pharmacist can tell you more about how these drugs compare.

Stelara vs. Tremfya

Tremfya and Stelara are both approved to treat the following conditions in adults: plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease. Tremfya is not approved for use in children, but Stelara can be used in children 6 years and older with plaque psoriasis or psoriatic arthritis.

Stelara contains the active ingredient ustekinumab, and Tremfya contains guselkumab. Both are biologic drugs (drugs made from living cells). Both drugs are given by subcutaneous injection, and by IV infusion for the first dose of ulcerative colitis treatment.

Your doctor or pharmacist can tell you more about how these drugs compare.

Stelara vs. Humira

Humira is approved to treat the same conditions as Stelara, plus several other conditions. Find out more about how Stelara compares with Humira.

Stelara vs. Cosentyx

Cosentyx is approved to treat the same conditions as Stelara as well as several other conditions. Learn more about how Stelara compares with Cosentyx.

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Stelara, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are prescribed off-label to treat these specific conditions. This is not a comprehensive list of alternatives for all the conditions Stelara treats.

For plaque psoriasisFor psoriatic arthritisFor Crohn’s diseaseFor ulcerative colitis
methotrexate (Otrexup, Rasuvo, Trexall, others)✓✓✓
apremilast (Otezla)✓✓
etanercept (Enbrel, Erelzi, Eticovo)✓✓
infliximab (Remicade, Avsola, Inflectra, Ixifi, Renflexis)✓✓✓✓
adalimumab (Humira, Hyrimoz, Cyltezo, Amjevita, Abrilada, Hulio)✓✓✓✓
certolizumab pegol (Cimzia)✓✓✓
secukinumab (Cosentyx)✓✓
ixekizumab (Taltz)✓✓
brodalumab (Siliq)✓✓
guselkumab (Tremfya)✓
tildrakizumab (Ilumya)✓
risankizumab (Skyrizi)✓
sulfasalazine (Azulfidine)✓✓
golimumab (Simponi, Simponi Aria)✓✓
abatacept (Orencia)✓
tofacitinib (Xeljanz, Xeljanz XR)✓✓
azathioprine (Azasan, Imuran)✓✓
natalizumab (Tysabri)✓
vedolizumab (Entyvio)✓✓
mesalamine (Apriso, Asacol HD, Canasa, Delzicol)✓

Stelara can interact with several other medications and therapies.

Different drug interactions can cause different effects in your body. For instance, some interactions can interfere with how well a drug works for you. Other interactions can increase a drug’s side effects or make them more severe.

Note: Stelara isn’t known to interact with any foods, so there aren’t any specific foods to avoid while you take Stelara.

Interactions with medications and vaccines

This section lists medications and vaccines that can interact with Stelara. These lists do not contain all drugs that may interact with Stelara. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Medications that can interact with Stelara include:

  • allergy shots, also called immunotherapy
  • warfarin (Jantoven)
  • certain drugs used during and after organ transplants, such as:
    • cyclosporine (Gengraf, Neoral)
    • tacrolimus (Prograf, Envarsus XR)
    • everolimus (Afinitor, Zortress)
    • sirolimus (Rapamune)

Vaccines that can interact with Stelara include:

  • Live vaccines, such as the vaccines for chickenpox (Varivax), yellow fever, and measles, mumps, and rubella (MMR). People in your household may also need to avoid live vaccines to avoid the transmission of germs to you.
  • The Bacillus Calmette-Guérin (BCG) vaccine, which is used to prevent tuberculosis. This vaccine should be avoided for 1 year before you start using Stelara, during your Stelara treatment, and for 1 year after you stop using Stelara.

If you receive non-live vaccines during Stelara treatment, your immune system might not be strong enough to protect you from the condition that the vaccine is used for. Talk with your doctor about whether it’s safe for you to get a non-live vaccine while you’re using Stelara.

Alcohol interaction

Alcohol is not known to interact with Stelara. But alcohol can worsen symptoms of the condition you’re using Stelara for. For example, alcohol may worsen symptoms of plaque psoriasis, ulcerative colitis, and Crohn’s disease. Your doctor may recommend avoiding or limiting alcohol consumption while you’re using Stelara.

If you have questions about how much alcohol is safe to drink while using Stelara, talk with your doctor or pharmacist.

It’s not known whether it’s safe to take Stelara while pregnant or breastfeeding. You can refer to this Stelara and reproductive health article for more information. If you have questions, talk with your doctor.

You should use Stelara according to your doctor or healthcare professional’s instructions.

Stelara is given as a subcutaneous injection. Your healthcare professional will give you your first dose. They may also show you or a caregiver how to inject the drug for your future doses.

If you’re using Stelara for Crohn’s disease or ulcerative colitis, your first dose will be given as an intravenous (IV) infusion. This is an injection into your vein that’s given over a period of time.

This infusion usually lasts at least 1 hour. You’ll get the infusion in a healthcare office or clinic. The rest of your doses will be given as subcutaneous injections, which can be given by either your healthcare professional or yourself.

The manufacturer of Stelara provides step-by-step instructions for injections. They also provide instructional videos that review how to use Stelara.

When to use

Stelara can be used at any time of the day. It doesn’t matter what time you choose to use the medication.

Stelara should be stored in the refrigerator at a temperature of 36°F to 46°F (2°C to 8°C). It should also be stored in its original carton until you’re ready to use the drug. This will protect it from direct light. Don’t freeze or shake vials or syringes of Stelara.

It’s important to go to all of your scheduled appointments if you’re receiving Stelara from a healthcare professional. If you’re self-injecting the drug, make sure to keep track on a calendar when your injections are needed.

Here are answers to some frequently asked questions about Stelara.

How long does Stelara stay in your system?

It can take 2.5 months to 9 months for Stelara to be completely cleared from your system. Exactly how long Stelara stays in the body can vary from person to person. It depends on which condition you’re using Stelara for, how long you’ve been taking this drug, and other factors.

Your doctor or a pharmacist can tell you more about how long Stelara is expected to stay in your system.

If I use Stelara for a long time, will I have withdrawal symptoms when I stop using it?

It’s possible that your condition may return or worsen if you stop using Stelara. This can lead to symptoms that may be confused with withdrawal symptoms. Withdrawal symptoms are uncomfortable effects that occur when you stop taking a drug or substance that your body is used to.

Don’t stop using Stelara unless your doctor recommends that you stop treatment. Once you stop using Stelara, your doctor will monitor you closely to determine whether you can safely remain off the medication.

Does Stelara have a black box warning?

No, Stelara doesn’t have a black box warning, which is also called a boxed warning. These warnings are used to alert healthcare professionals and patients about very serious side effects that can happen with some drugs.

Stelara can cause serious side effects. But the Food and Drug Administration (FDA) hasn’t required the manufacturers of Stelara to include a black box warning with this medication.

Before using Stelara, talk with your doctor about your health history. Stelara may not be right for you if you have certain medical conditions or if certain factors apply to you. These include:

  • infections, including past infections such as tuberculosis (TB)
  • cancer, including skin cancer
  • receiving allergy immunotherapy shots
  • allergic reaction to Stelara or any of its ingredients, or to any of Stelara’s biosimilars
  • scheduled or upcoming vaccines
  • new or changing areas of psoriasis
  • history of phototherapy (light therapy) treatment
  • reduced immune system activity (also called a weakened immune system)
  • history of neurological conditions, such as seizures or posterior reversible encephalopathy syndrome
  • latex allergy
  • pregnancy
  • breastfeeding

Note: For more information about the potential negative effects of Stelara, see the “Stelara side effects” section.

Do not use more Stelara than your doctor recommends.

If you think you’ve injected or received too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.