Stelara (ustekinumab) is a prescription drug that’s used to treat certain autoimmune conditions, such as plaque psoriasis. Stelara can cause side effects that range from mild to serious. Examples include infections, headache, and fatigue.

Specifically, Stelara is used in adults to treat:

It can also be used to treat plaque psoriasis and psoriatic arthritis in certain children.

The active ingredient in Stelara is ustekinumab. (An active ingredient is what makes a drug work.) The drug comes as a liquid solution you receive as a subcutaneous injection (an injection under your skin). It also comes as a liquid solution you receive as an intravenous (IV) infusion (an injection into your vein that’s given over time).

Keep reading to learn about the common, mild, and serious side effects (also called adverse effects) that Stelara can cause. For a general overview of the drug, including details about its uses, see this article.

These are just a few of the more common side effects reported by people who took Stelara in studies. These side effects can vary depending on what condition the drug is being used to treat.

More common side effects in people receiving Stelara for plaque psoriasis include:

The most common side effect in people receiving the starting dosage† of Stelara for Crohn’s disease is:

  • vomiting

More common side effects in people receiving the long-term dosage† of Stelara for Crohn’s disease include:

  • infections, such as the common cold, vaginal yeast infection, sinus infection, and bronchitis*
  • injection site reactions*
  • itching

The most common side effect in people receiving the starting dosage† of Stelara for ulcerative colitis (UC) is:

More common side effects in people receiving the long-term dosage† of Stelara for UC include:

* To learn more about this side effect, see the “Side effects explained” section below.
† Your starting dosage of Stelara for UC or Crohn’s disease will be higher than what you eventually receive long term.

Stelara may cause you to experience some mild side effects. Mild side effects that have been reported in people receiving Stelara for plaque psoriasis or psoriatic arthritis include:

The most common side effect reported in people receiving the starting dosage† of Stelara for Crohn’s disease is:

  • vomiting

Mild side effects that have been reported in people receiving the long-term dosage† of Stelara for Crohn’s disease include:

  • infections, such as the common cold, vaginal yeast infection, sinus infection, or bronchitis*
  • injection site reactions*
  • itching

The most common side effect reported in people receiving the starting dosage† of Stelara for ulcerative colitis (UC) is:

  • the common cold

Mild side effects that have been reported in people receiving the long-term dosage† of Stelara for UC include:

  • infections, such as a sinus infection or the common cold*
  • headache*
  • abdominal pain
  • fever
  • diarrhea
  • fatigue*
  • nausea

* To learn more about this side effect, see the “Side effects explained” section below.
† Your starting dosage of Stelara for UC or Crohn’s disease will be higher than what you eventually receive long term.

In most cases, these side effects should be temporary. And some may be easily managed, too. But if you have any symptoms that are ongoing or that bother you, talk with your doctor or pharmacist. And don’t stop using Stelara unless your doctor recommends it.

Stelara may cause mild side effects other than the ones listed above. See the Stelara prescribing information for details.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Stelara, visit MedWatch.

Serious side effects of Stelara are rare relative to its mild side effects, but they can still occur. Serious side effects that have been reported with Stelara include:

* Noninfectious pneumonia was not reported in studies of Stelara. But this side effect was reported after the drug became available.
† To learn more about this side effect, see the “Side effects explained” section below.

If you develop serious side effects while receiving Stelara, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Get answers to some frequently asked questions about Stelara’s side effects.

Does Stelara cause weight gain?

No, Stelara shouldn’t cause you to have weight gain. This side effect wasn’t reported in studies of the drug.

If you have weight gain while receiving Stelara, talk with your doctor. In some cases, it’s possible for weight gain to be related to the symptoms of your condition easing.

For example, ulcerative colitis (UC) and Crohn’s disease may cause weight loss due to symptoms such as diarrhea. Treating UC or Crohn’s disease can allow the body to absorb more nutrients, which may cause weight gain.

If you have concerns about weight gain during Stelara treatment, talk with your doctor.

Is hair loss a side effect of Stelara?

No, you shouldn’t have hair loss from Stelara. Hair loss wasn’t reported in studies of the drug.

But, some other medications that may be used to treat autoimmune conditions can cause hair loss. Examples include Trexall (methotrexate) and Humira (adalimumab).

If you experience hair loss while receiving Stelara, talk with your doctor about what may be causing this side effect.

Can Stelara cause anxiety or changes in mood?

You shouldn’t experience anxiety from receiving Stelara. This wasn’t a side effect reported in studies of people using this drug.

Although mood changes aren’t a side effect of Stelara, depression was reported as a rare side effect in studies. And while anxiety isn’t a direct side effect of Stelara, it can be a symptom of depression.

Other symptoms of depression include:

If you have any symptoms of depression, anxiety, or other mood changes during treatment with Stelara, talk with your doctor. They’ll check to see what’s causing the change and recommend the best way to treat it.

Are there any long-term side effects of Stelara?

Yes, it’s possible for you to have long-term side effects from receiving Stelara. In many cases, side effects that you develop may ease over time or stop if you end treatment. But other side effects may last throughout treatment or even after stopping treatment.

For example, you may have headaches or injection site reactions with each of your Stelara doses. These side effects may go away after receiving your dose or when you stop treatment with Stelara. But Stelara can also cause long-term side effects, such as cancer, which may occur even after you stop receiving the medication.

If you’re concerned about long-term side effects from Stelara, talk with your doctor.

Will stopping Stelara treatment cause any side effects?

No, you shouldn’t have withdrawal symptoms when you stop Stelara treatment. Withdrawal symptoms are side effects that can happen when you stop taking a drug that your body has become dependent on. (With dependence, your body needs the drug to function as usual.) These symptoms weren’t reported in studies of people receiving Stelara.

But it’s possible for you to have worsening symptoms of your condition when you stop receiving Stelara. For example, if you’re using the medication for ulcerative colitis (UC), you may notice an increase in your UC symptoms when you stop treatment.

If you would like to stop Stelara treatment, talk with your doctor first. You should not stop receiving Stelara without first discussing it with your doctor.

Learn more about some of the side effects Stelara may cause.

Headache

You may have headaches while receiving Stelara. Headaches were a common side effect reported in people using Stelara for plaque psoriasis, psoriatic arthritis, or ulcerative colitis. It wasn’t a side effect reported in people receiving Stelara for Crohn’s disease.

Note that headaches may be a sign of a more serious condition called posterior reversible encephalopathy syndrome (PRES). Although rare, PRES is a neurological condition that can cause swelling of the brain. (A neurological condition is one that affects the brain or nerves.) People with PRES may also have other symptoms, including seizures, confusion, or eye-related side effects, such as blurred vision.

What might help

Be sure to tell your doctor right away if you’re having headaches. They’ll determine what is causing your headaches. They’ll also let you know whether your headaches may be related to a more serious side effect, such as PRES. In such cases, your doctor will recommend that you stop receiving Stelara so they can treat this serious side effect.

If you’re having frequent headaches that are bothersome to you, talk with your doctor about the best way to manage them. They may recommend that you take an over-the-counter pain reliever, such as Tylenol (acetaminophen) or Advil (ibuprofen). Or they might have other suggestions.

Fatigue

You may feel more tired or weak while receiving Stelara. Fatigue (low energy) was one of the most common side effects reported by people using this medication.

What might help

If you’re feeling fatigued during Stelara treatment, talk with your doctor. They may be able to recommend ways to reduce this side effect.

Injection site reactions

Stelara is sometimes given as a subcutaneous injection (an injection under your skin), so you may have reactions at the site of injection. These skin side effects may include itching, irritation, pain, and discoloration at the injection site.

Injection site discoloration and itching were commonly reported in people receiving Stelara for Crohn’s disease. But these side effects weren’t as common in people using the medication for other conditions.

What might help

In many cases, injection site reactions will go away on their own.

But if you have an injection site reaction that is bothersome, doesn’t go away, or gets worse, tell your doctor. They’ll check whether an infection or other issue is causing the problem. They may also be able to give you some tips on how to reduce this side effect. For example, they may suggest an over-the-counter medication you take by mouth, such as Benadryl (diphenhydramine).

Allergic reaction

Like most drugs, Stelara can cause an allergic reaction in some people.

Symptoms can be mild or serious and can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

Stelara also has latex in the needle cover of one of the forms it comes in, the prefilled syringe. You shouldn’t handle the needle cover if you’re sensitive to latex. If you have a latex allergy, talk with your doctor before starting Stelara treatment.

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. To help manage symptoms, they may suggest an over-the-counter antihistamine you take by mouth, such as Benadryl. Or they may recommend a product you apply to your skin, such as hydrocortisone cream.

If your doctor confirms you had a mild allergic reaction to Stelara, they’ll decide whether you should continue using it.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you had a serious allergic reaction to Stelara, they may have you switch to a different treatment.

Infections

You may have infections more often while using Stelara. Infections were one of the most common side effects that people receiving Stelara reported.

Examples of infections that were reported during treatment with Stelara include:

During treatment with Stelara, you should watch for symptoms of infection. Symptoms to look out for include:

What might help

Monitor yourself for symptoms of infection while you’re receiving Stelara. If you develop symptoms of an infection during treatment, tell your doctor. They can determine whether you need antibiotics or another treatment for it.

Keeping track of side effects

During Stelara treatment, consider keeping notes on any side effects you’re having. Then, you can share this information with your doctor. This is especially helpful to do when you first start taking new drugs or using a combination of treatments.

Your side effect notes can include things such as:

  • what dose of drug you had received when you had the side effect
  • how soon after starting that dose you had the side effect
  • what your symptoms were from the side effect
  • how it affected your daily activities
  • what other medications you were also taking
  • any other information you feel is important

Keeping notes and sharing them with your doctor will help your doctor learn more about how Stelara affects you. And your doctor can use this information to adjust your treatment plan if needed.

Stelara may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you receive Stelara. The list below includes factors to consider.

Active infections: If you have any infections, your doctor will recommend treatment for them before you start receiving Stelara. Because Stelara may weaken your immune system, it can increase your risk of infections or make infections you already have worse. Before starting Stelara treatment, tell your doctor if you have any symptoms of infection, such as a fever. (For more information, see the “Side effects explained” section above.)

Tuberculosis: If you have or have had tuberculosis (TB), be sure to tell your doctor. Even if you’ve never had TB, they’ll test you for it before you receive Stelara. If you have TB, your doctor will recommend treating it before you start receiving the drug. While you’re receiving Stelara, your doctor will likely watch you closely for signs and symptoms of TB.

Recent vaccinations: If you’ve recently received any vaccines, tell your doctor before you start receiving Stelara. It may not be safe for you to begin Stelara treatment soon after receiving a live vaccine. (Live vaccines contain a small amount of a weakened live virus or bacteria.) Also, you should not receive live vaccines during Stelara treatment, though other vaccines could be safe. Your doctor may want to make sure you’re up to date on your vaccinations before you start receiving Stelara.

Allergic reaction: If you’ve had an allergic reaction to Stelara or any of its ingredients, your doctor will likely not prescribe Stelara. Ask your doctor what other medications are better options for you.

The needle cover on the prefilled Stelara syringe contains latex. If you have a latex allergy, you shouldn’t handle the needle cover of the syringe. Before you start receiving Stelara, tell your doctor if you’re allergic to latex.

Cancer: Stelara may increase your risk of developing certain kinds of cancer, such as skin cancer. If you already have cancer, it’s not known what effects the medication may have on your cancer. Talk with your doctor if you have or have had cancer to see whether Stelara may be a safe treatment option for you.

Alcohol and Stelara

It should be safe to drink alcohol during Stelara treatment.

However, some people receive Stelara along with methotrexate to treat psoriatic arthritis. Methotrexate can cause liver damage. Alcohol may worsen this side effect of methotrexate.

If you would like to drink alcohol during treatment, talk with your doctor about how much is safe to consume.

Pregnancy and breastfeeding while receiving Stelara

It’s not known whether Stelara is safe to receive during pregnancy. Currently, there isn’t enough information on whether the drug may have an effect on a developing fetus. If you’re pregnant or planning to become pregnant, talk with your doctor about whether you should receive Stelara.

It’s thought that Stelara passes into breast milk in small amounts. If you’re breastfeeding or planning to breastfeed, talk with your doctor about whether Stelara is the right treatment option for you.

Stelara is an effective treatment for certain autoimmune conditions. If you’re considering it as a treatment option, it’s helpful to learn about the side effects it might cause.

If you have questions about your risk of side effects from Stelara, talk with your doctor. Here are a few questions you could ask them:

  • Is there a higher risk of side effects with my first Stelara infusion?
  • How can I reduce my risk of side effects during treatment?
  • What should I do if I become pregnant while I’m receiving Stelara?
  • If I experience side effects from Stelara, can my dose be changed?

To learn more about Stelara, see these articles:

To get information on different conditions and tips for improving your health, subscribe to any of Healthline’s newsletters. You may also want to check out the online communities at Bezzy. It’s a place where people with certain conditions can find support and connect with others.

Q:

Am I at an increased risk of side effects if I’m also taking other medications with Stelara, such as Trexall (methotrexate), to treat my condition?

Anonymous

A:

Stelara can be used in adults to treat psoriatic arthritis alone or with the drug methotrexate.

Using Stelara with methotrexate may increase your risk of serious infections.

If you develop symptoms of infection, contact your doctor immediately. Symptoms to look out for include:

Methotrexate can also have additional side effects when used for psoriatic arthritis, such as liver damage.

To find out whether using Stelara with methotrexate may be a safe treatment option for you, talk with your doctor.

The Healthline Pharmacist TeamAnswers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.
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Disclaimer: Healthline 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.