Stelara’s Side Effects: What to Know

Stelara is a brand-name prescription drug. It’s a type of medication called a monoclonal antibody.

Stelara comes as a solution. It’s given as either a subcutaneous injection or an IV infusion. Stelara contains the active drug ustekinumab.

Stelara is approved by the Food and Drug Administration (FDA) to treat the following conditions in adults:

• Crohn’s disease
• ulcerative colitis
• plaque psoriasis
• psoriatic arthritis

It’s also approved to treat plaque psoriasis in children ages 6 years and older. For these purposes, doctors typically prescribe Stelara for long-term use.

Similar to other drugs, Stelara may cause adverse effects (side effects). Read below for information about possible side effects, including common, mild, and serious ones.

For a general overview of Stelara, including details about its uses, see this article.

If you’d like to take Stelara, search here to find a healthcare professional who might prescribe it.

Some of the more common side effects of Stelara that occurred during clinical studies are listed below. These side effects can vary depending on the condition Stelara is being used to treat.

More common side effects of Stelara in people with Crohn’s disease include:

• injection site reaction*
• itching
• infection, such as urinary tract infection (UTI), vaginal yeast infection, bronchitis, or the common cold
• vomiting

More common side effects of Stelara in people with ulcerative colitis include:

• fatigue*
• headache*
• digestive problems, such as abdominal pain, diarrhea, or nausea
• fever
• infection, such as the common cold or the flu

More common side effects of Stelara in people with plaque psoriasis or psoriatic arthritis include:

• fatigue*
• headache*
• infection, such as the common cold

* For more information about this side effect, see “Side effects explained” below.

Stelara can cause mild side effects, which are listed below. These side effects can vary depending on the condition Stelara is being used to treat. However, this list doesn’t include all possible mild side effects. To learn more about Stelara’s side effects, view the drug’s prescribing information.

Stelara’s mild side effects in people with Crohn’s disease include:

• injection site reaction*
• itching
• infection, such as urinary tract infection (UTI), vaginal yeast infection, bronchitis, or the common cold
• vomiting
• weakness
• acne
• itching

Stelara’s mild side effects in people with ulcerative colitis include:

• fatigue*
• headache*
• digestive problems, such as abdominal pain, diarrhea, or nausea
• fever
• infection, such as the common cold or the flu

Stelara’s mild side effects in people with plaque psoriasis include:

• fatigue*
• headache*
• injection site reaction*
• infection, such as the common cold
• diarrhea
• dizziness
• back, throat, or muscle pain

Stelara’s mild side effects in people with psoriatic arthritis include:

• fatigue*
• headache*
• infection, such as the common cold
• joint pain
• nausea
• dental infection

The side effects listed above may last only a few days to weeks. However, some side effects may last longer or become severe or bothersome. Tell your doctor or pharmacist if you have concerns about side effects with Stelara.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Stelara and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effects explained” below.

It’s possible to have serious side effects with Stelara. These side effects can vary depending on the condition Stelara is being used to treat.

Serious side effects are listed below, but this list may not include all possibilities. To learn more about Stelara’s side effects, view the drug’s prescribing information.

Call your doctor right away if you have serious side effects with Stelara. However, if you think you’re having a medical emergency or have life threatening side effects, call 911 or your local emergency number.

Serious side effects of Stelara and their possible symptoms include:

• Cancers, such as skin, prostate, colorectal, and breast cancer. Symptoms can vary depending on the specific type of cancer but may include:
  • fatigue
  • weight loss
  • moles or spots on the skin that change in size or color
  • painful or difficult urination
  • pain, swelling, or discoloration of the nipple or breast
  • changes in bowel movements, such as constipation, diarrhea, or trouble fully emptying your bowels
• Serious infection, such as tuberculosis or pneumonia. Symptoms can vary depending on the specific type of infection but may include:
  • fatigue
  • fever
  • cough
  • chest tightness or pain
• Brain condition called posterior reversible leukoencephalopathy syndrome.*
• Mood changes, including depression.*
• Allergic reaction.*

* For more information about this side effect, see “Side effects explained” below.

Here are some common questions about the drug’s side effects and answers to them. Talk with your doctor if you have other questions about this drug.

No, Stelara isn’t likely to cause weight gain, hair loss, or anxiety. These symptoms weren’t reported as side effects in clinical studies of the drug.

Keep in mind that weight loss can be a symptom of Crohn’s disease and ulcerative colitis. And Stelara is approved to treat both of these conditions. With treatment, symptoms of these conditions may begin to ease, and you may gain weight. This is likely a result of the conditions improving rather than being a side effect of Stelara.

Stelara is also approved to treat plaque psoriasis and psoriatic arthritis. And hair loss can be a symptom of psoriasis. Having psoriasis or psoriatic arthritis can also increase your risk for anxiety. If you have these symptoms while taking Stelara, talk with your doctor. They can help determine if the drug is working for your condition.

Yes, it’s possible to have different side effects from Stelara depending on how you’re receiving the drug. You’ll be given Stelara as either an injection (shot) under your skin or an infusion into your vein.

In clinical studies, the most common side effects from Stelara infusions were vomiting and the common cold. You may have the same side effects with Stelara injections, but you may have different side effects as well.

For example, with Stelara injections, you may have certain injection site reactions around the area where the drug is injected. For details, see “Injection site reaction” in the “Stelara: Side effects explained” section below.

To learn more about what to expect with Stelara infusions or injections, talk with your doctor.

Yes, Stelara can cause neurological side effects. These are side effects that affect your brain, spinal cord, or nerves.

Stelara may cause mild neurological side effects such as headache and dizziness. But Stelara can also cause a more serious brain condition called posterior reversible leukoencephalopathy syndrome (PRES). For more information about headache and PRES, see the “Stelara: Side effects explained” section below.

If you’re concerned about neurological side effects with Stelara, talk with your doctor.

No, you aren’t likely to have withdrawal symptoms after stopping Stelara. Withdrawal symptoms are side effects that may happen after you stop taking a drug your body has become dependent upon. But these symptoms weren’t reported in clinical studies of Stelara.

However, it’s possible that the condition you’re using Stelara to treat may worsen after stopping the drug. So it’s important that you don’t stop taking Stelara without first talking with your doctor. They can monitor your condition and may recommend a different treatment option if you’d like to stop Stelara.

No, Stelara isn’t likely to cause constipation or eye-related side effects. These weren’t reported in clinical studies of the drug.

However, keep in mind that constipation can be a symptom of colorectal cancer, which is a rare but serious side effect of Stelara. Also, eye-related side effects, such as vision changes, can be a symptom of a rare but serious brain condition. This condition, called posterior reversible leukoencephalopathy syndrome (PRES), is also a possible serious side effect of Stelara. For more information about PRES, see the “Stelara: Side effects explained” section below.

If you have constipation or eye-related side effects while taking Stelara, tell your doctor right away. They may order tests to determine if your symptoms are caused by a more serious condition.

Yes, long-term side effects are possible with Stelara. Most of Stelara’s side effects should ease over time. However, certain side effects of the drug could be long-term ones.

For example, in rare cases, Stelara may cause cancer as a long-term side effect.

Stelara can also cause a rare but serious brain condition called posterior reversible leukoencephalopathy syndrome (PRES). In some cases, PRES has been reported after people have taken Stelara for more than a year. For more information about PRES, see the “Stelara: Side effects explained” section below.

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

Here’s detailed information about some of Stelara’s side effects.

A brain condition called posterior reversible leukoencephalopathy syndrome (PRES) may occur with Stelara. In some cases, PRES has been reported after people have taken Stelara for more than a year. However, this side effect was rare during clinical studies of the drug.

Symptoms of PRES can include:

• headache
• seizures
• vision changes
• loss of consciousness
• confusion

If you have symptoms of PRES with Stelara, call 911 or your local emergency number right away. This condition can be life threatening if it isn’t treated.

Stelara may cause mood changes, including depression. This side effect was rare in clinical studies of the drug.

Depression itself can cause mood changes such as feeling more irritable, angry, anxious, or sad than usual. Other symptoms of depression include:

• loss of interest in activities you once enjoyed
• weight changes
• fatigue
• changes in sleep patterns, such as sleeping more or less than usual

Keep in mind that depression and other mood changes can also be symptoms of the conditions Stelara is approved to treat. These conditions are Crohn’s disease, ulcerative colitis, psoriasis, and psoriatic arthritis. And they can increase your risk for depression and other mental health conditions.

So you may have mood changes related to your condition while you’re taking Stelara. But these symptoms may not be a side effect of the drug itself.

If you have mood changes or symptoms of depression while taking Stelara, talk with your doctor. They can help you decide if your symptoms are a side effect of Stelara or have another cause. And your doctor can recommend treatment if needed.

Fatigue is possible with Stelara. This was one of the most common side effects in clinical studies of the drug.

Symptoms of fatigue can include:

• sleepiness
• irritability
• trouble concentrating
• muscle aches

If you have fatigue while taking Stelara, talk with your doctor. The side effect is likely to go away as your body gets used to the drug. However, if your fatigue becomes bothersome or doesn’t go away, your doctor can suggest ways to help improve your energy.

Headaches may occur with Stelara. This was a very common side effect in clinical studies of the drug.

Keep in mind that headache can also be a symptom of a serious brain condition called posterior reversible leukoencephalopathy syndrome (PRES). This condition is a rare but serious side effect of Stelara. For details, see “Brain condition called posterior reversible leukoencephalopathy syndrome” above.

If you have a headache while taking Stelara, talk with your doctor. They may ask you if you have any other symptoms of PRES. And they may order tests to check for other signs of PRES.

If your headache is mild, your doctor may suggest you take over-the-counter pain relievers to help ease it. These may include medications such as acetaminophen (Tylenol) or ibuprofen (Advil, Motrin). However, be sure to ask your doctor or pharmacist before taking any new medications with Stelara.

Using Stelara may cause an injection site reaction. This can happen around the area where the drug is injected.

In clinical studies, the most common injection site reaction with Stelara was redness or discoloration. But Stelara injections may cause other skin side effects as well, such as:

• pain
• swelling
• itching
• bleeding
• bruising
• irritation

To lower your risk of an injection site reaction, it’s important to rotate injection sites each time you inject Stelara. You can inject Stelara under the skin of your abdomen, upper arm, thigh, or buttocks.

Also, Stelara may not work as well for your condition if it’s injected into areas of skin that are bruised, tender, or hard. So be sure to avoid injecting Stelara into these areas.

If you’re concerned about having site reactions with Stelara, talk with your doctor. They can suggest other ways to help relieve these reactions.

Be sure to talk with your doctor about your health history before you take Stelara. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include those listed below.

Cancer. In rare cases, Stelara may cause certain cancers. It isn’t known if Stelara is safe for people who currently have cancer or have had cancer in the past. Be sure to tell your doctor if you have cancer now or have a history of it. They can discuss whether Stelara is the right treatment option for you.

Infection, including tuberculosis (TB). Tell your doctor if you have any active infections. Also, tell them if you have TB or have had it in the past. Stelara can increase your risk of serious infection. The drug can also cause a TB infection to become active. Before taking Stelara, your doctor will test you for TB. If you have TB or any other infection, your doctor will likely treat your infection before starting Stelara treatment.

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 may be better options for you.

Allergy to rubber or latex. If you have an allergy to rubber or latex, you may have an allergic reaction to Stelara. This is because the cover of the needle on Stelara syringes contains a latex-like form of rubber. Be sure your doctor knows if you have an allergy to rubber or latex before you start using Stelara. They’ll recommend if a drug other than Stelara is a better treatment option for you.

There aren’t any known safety issues with drinking alcohol while taking Stelara. If you drink alcohol, talk with your doctor about the amount that’s safe to drink while using the drug.

It isn’t known for sure whether Stelara is safe to take during pregnancy or while breastfeeding.

Animal studies have shown harm to offspring when Stelara was given to pregnant animals. And animal studies have also shown that Stelara may pass into breast milk. However, keep in mind that animal studies don’t always predict what will happen in humans.

If you’re pregnant, breastfeeding, or planning either, talk with your doctor before taking Stelara. They can offer advice about the risks and benefits of using the drug during these times.

Talk with your doctor or pharmacist to find out more information about Stelara. If you have questions about the drug’s side effects, your pharmacist or healthcare professional can help answer them for you.

In addition to discussing Stelara with your doctor, you may find these articles helpful in learning more.

• Overview of Stelara. To read an overview of Stelara, see this article.
• Drug comparison. To learn how Stelara compares with Cosentyx, read this article. And to see a comparison with Humira, check out this article.
• Details about Stelara’s uses. To learn more about the conditions Stelara is used to treat, see these articles about Crohn’s disease, ulcerative colitis, psoriasis, and psoriatic arthritis.

Disclaimer: Healthgrades 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.