Stelara (ustekinumab) is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat the following in certain situations:

Stelara is typically used as a long-term treatment. Although Stelara doesn’t cure the conditions it treats, it may help you reach remission depending on the condition you have. Remission means that you have very few or no symptoms.

Here are some fast facts on Stelara:

Like other drugs, Stelara can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Stelara, including details about its uses, see this article.

Stelara can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who took Stelara in clinical trials:

  • fatigue (see “Side effect specifics” below)
  • headache
  • redness at the injection site
  • nausea
  • upper respiratory infections, such as the common cold, bronchitis, or sinus infections

Mild side effects can occur with Stelara use. This list doesn’t include all possible mild side effects reported with the drug. For more information, you can refer to the Stelara medication guide.

Mild side effects of Stelara can include:

These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

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

Rarely, Stelara may cause serious side effects. Serious side effects weren’t common in clinical trials. The list below may not include all possible reported serious side effects of the drug. For more information, you can refer to the Stelara medication guide.

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

Serious side effects and their symptoms can include:

See “Side effect Specifics” below for details about these side effects.

Stelara may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.

Is anxiety a side effect of Stelara?

No. In clinical trials, anxiety wasn’t reported as a side effect in people taking Stelara.

In a study of adults with plaque psoriasis, a small percentage of people taking Stelara reported depression as a side effect. A few people taking a placebo (a treatment without an active drug) also reported depression as a side effect.

Some symptoms of depression and anxiety can overlap. These symptoms include fatigue (lack of energy), trouble concentrating or thinking, and feeling restless or on edge. And, fatigue can be a side effect of Stelara.

It’s important to note that depression isn’t considered a side effect of Stelara. This is because it affected so few people, and it was almost equally likely to occur whether people took Stelara or a placebo.

If you experience changes in your mood or thinking while taking Stelara, talk with your doctor. They can help determine whether you may be experiencing side effects from Stelara. They can also work with you to determine the best treatment for your condition.

Are there any side effects from stopping Stelara treatment?

No, stopping Stelara use shouldn’t cause side effects.

However, if you stop taking Stelara, the condition you’re taking it to treat may come back or get worse. Keep in mind that this worsening of symptoms isn’t the same as side effects from stopping Stelara treatment.

You shouldn’t stop taking Stelara without first talking with your doctor. If they recommend that you stop using Stelara, they’ll likely monitor you for any symptoms of your condition getting worse.

Can Stelara cause weight gain?

No. Weight gain wasn’t reported as a side effect by people taking Stelara in clinical trials. However, people with Crohn’s disease, which Stelara is approved to treat, often experience weight loss.

Talk with your doctor if you’re unintentionally gaining weight while taking Stelara. They can help identify possible causes. And, they can recommend whether any actions should be taken to help you maintain a healthy weight.

Is hair loss one of Stelara’s side effects?

In clinical trials, people taking Stelara didn’t report hair loss as a side effect.

However, Stelara is approved to treat plaque psoriasis. And hair loss can be a symptom of plaque psoriasis.

If you’re experiencing hair loss while being treated with Stelara, talk with your doctor. They can check for other possible causes of hair loss, and may be able to recommend ways to help reduce hair loss.

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

Reversible posterior leukoencephalopathy syndrome

Reversible posterior leukoencephalopathy syndrome (RPLS) is a very rare but serious side effect reported in clinical trials of Stelara. It’s also known as posterior reversible encephalopathy syndrome.

RPLS causes swelling in your brain and mainly results in neurologic side effects (which affect your brain or spinal cord). Symptoms develop very quickly over a few hours. They can include:

  • changes in consciousness, such as feeling suddenly confused or agitated
  • headache
  • seizures, which in rare cases may lead to loss of consciousness or coma
  • sudden increases in blood pressure
  • visual problems, such as blurred vision

RPLS in people taking Stelara is rare. It’s important to note, though, that RPLS can be fatal if it isn’t treated quickly. With fast treatment, there usually aren’t long-term effects from RPLS. However, long-term side effects are rare but are possible, such as brain damage.

It isn’t known why Stelara can cause RPLS. Other medications, such as cyclosporine, can also cause RPLS as a rare side effect. Researchers are still trying to determine why certain medications can cause this syndrome.

What you can do

If you have symptoms of RPLS while using Stelara, call 911 or your local emergency number. Or, go to your closest emergency room as soon as possible.

Fatigue

Fatigue is a potential side effect of Stelara. Fatigue refers to a lack of energy. This may cause you to feel more tired than usual, no matter how much sleep you’ve had.

Fatigue was slightly more common than other side effects of Stelara. It occurred in only a small percentage of people taking the drug in clinical trials. Almost as many people taking a placebo (a treatment without an active drug) in trials also reported fatigue.

What you can do

Fatigue often goes away after a few days or weeks of taking Stelara. If your fatigue is mild but bothersome, talk with your doctor. They may be able to suggest ways you can boost your energy.

You should also talk with your doctor if you have fatigue that doesn’t go away or causes problems with your daily life. They may recommend that you try a different medication to treat your condition.

Joint pain

It isn’t known for sure whether Stelara causes joint pain.

In clinical trials, Stelara rarely caused muscle pain, but joint pain was not reported. A small number of people taking a placebo (a treatment without an active drug) also had muscle pain.

It’s important to note that this study included people with psoriatic arthritis, which Stelara is used to treat. And joint pain is a common symptom of psoriatic arthritis.

What you can do

If you experience joint pain while taking Stelara, talk with your doctor. They may be able to recommend ways to reduce your pain. Or, they may recommend that you try a different medication to treat your condition.

Serious infections

Taking Stelara may increase your risk for certain infections. These may include bacterial, fungal, and viral infections, some of which can be serious. This is because Stelara may decrease your immune system’s ability to fight infection.

Serious infections from taking Stelara are rare. In clinical trials, some serious infections required treatment in the hospital.

Serious infections reported in people taking Stelara in clinical trials included:

While taking Stelara, your doctor will monitor you for symptoms of TB or other infections. Symptoms can vary based on the type of infection you have, but general symptoms of an infection may include:

  • a burning sensation when you urinate
  • abdominal (belly) pain
  • chills, fever, or sweats
  • cough
  • coughing up blood
  • feeling very tired
  • producing more urine than usual
  • shortness of breath
  • unintended weight loss

If you may be at risk for TB, your doctor may prescribe medications to treat TB.

What you can do

Before you begin treatment with Stelara, your doctor will test you for TB. You should let your doctor know about any infections you may have before you start taking Stelara. They’ll likely want to treat any infections before you begin using the drug.

Talk with your doctor if you notice any symptoms of an infection while taking Stelara. Your doctor may want to examine you if you have any of the above symptoms. They may recommend over-the-counter treatments, or in serious cases, treatment in the hospital.

Cancer

Stelara works by decreasing the activity of your immune system. This may increase your risk for cancer, particularly a certain skin cancer known as nonmelanoma skin cancer. However, it’s important to note that cancer may be a very rare side effect of Stelara.

According to Stelara’s manufacturer, you may be at higher risk for nonmelanoma skin cancer while taking the drug if you:

  • are older than age 60 years
  • have received immunotherapy for a prolonged period of time
  • have been treated with a type of phototherapy (light therapy) called PUVA

More data may be needed before it’s known for sure how much Stelara may contribute to development of new nonmelanoma cancers.

Other types of cancer, such as lung and breast cancer, were very rarely reported by people taking Stelara in clinical trials. These cancers also occurred in about equal numbers of people taking a placebo (a treatment without an active drug) in these trials.

In studies of Stelara for treating Crohn’s disease and ulcerative colitis, rates of new cancers were so low that the researchers couldn’t come to any conclusions about or whether or not the drug contributed to cancer development.

Symptoms of cancer may include:

  • unexplained weight loss
  • fatigue (lack of energy)
  • cough
  • skin changes

What you can do

Before taking Stelara, be sure to tell your doctor about any history of cancer you may have. While taking Stelara, your doctor will monitor your skin for new growths. If you notice new skin growths (such as new moles) while taking Stelara, you should let your doctor know.

Allergic reaction

As with most drugs, Stelara can cause an allergic reaction in some people. In clinical studies, a very small number of people had an allergic reaction while taking Stelara.

Symptoms can be mild or serious and can include:

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

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Stelara. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

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:

Infections. Stelara may decrease your immune system’s ability to fight infections. This can increase your risk for serious infections. If you’ve had certain infections in the past, taking Stelara may cause the infection to flare up.

It’s important to tell your doctor about any past infections you’ve had, especially tuberculosis. You should also let them know if you currently have an infection. If you have an active infection, your doctor will likely treat the infection before you start taking Stelara.

Recent bacillus Calmette-Guérin vaccination. If you’ve received the bacillus Calmette-Guérin (BCG) vaccine in the past year, your doctor may recommend a treatment other than Stelara. The BCG vaccine is commonly given in some countries to vaccinate against TB, but isn’t widely used in the United States.

The BCG vaccine is an example of a live vaccine, and you shouldn’t get live vaccines while taking Stelara. Live vaccines contain a small amount of a live germ or virus. Other examples of live vaccines include the chickenpox vaccine, and measles, mumps, and rubella (MMR). Stelara decreaSes the activity of your immune system. And live vaccines could make people with weakened immune systems sick.

In addition to avoiding live vaccines during Stelara treatment, make sure that you’re up to date on your vaccinations before starting Stelara.

Cancer. If you’ve had cancer in the past, using Stelara may increase your risk for developing cancer. The drug works by decreasing the activity of your immune system. This may prevent your immune system from killing cancer cells or preventing cancer cells from spreading.

Before taking Stelara, talk with your doctor about any history of cancer you may have. They can help determine if Stelara is safe for you to take.

Allergic reaction. You shouldn’t take Stelara if you’ve ever had an allergic reaction to Stelara or any of its ingredients. Talk with your doctor about what other treatments are better choices for you.

Latex allergy. Needle covers on prefilled Stelara syringes contain latex. If you have a latex allergy, you shouldn’t handle needle covers on Stelara prefilled syringes. Talk with your doctor about finding the best treatment option for your condition if you have a latex allergy.

Alcohol use with Stelara

There aren’t any known interactions between Stelara and alcohol.

Talk with your doctor about how much, if any, alcohol is safe for you to drink while taking Stelara.

Pregnancy and breastfeeding while taking Stelara

It isn’t known whether Stelara is safe to take while either pregnant or breastfeeding. Studies in pregnant animals didn’t show harm to the fetus when Stelara was given to pregnant females. Animal studies also showed that, when Stelara was given to lactating females, the drug passed into breast milk.

However, it’s important to remember that animal studies don’t always predict what will happen in people. There isn’t enough information to know for sure how the drug may affect human pregnancy or breastfeeding.

If you have additional questions about using Stelara while pregnant or breastfeeding, talk with your doctor.

If you took Stelara during a past pregnancy or if you’re currently taking it during pregnancy, you’re encouraged join a pregnancy registry. The goal of this registry is to help doctors and people taking the drug learn more about the drug’s safety. Consider calling the registry at 866-626-6847. Or you can visit the program website.

Stelara is approved to treat the following in certain conditions:

Regardless of the condition it’s used to treat, side effects from Stelara aren’t common. Most side effects that occur are usually mild, and tend to go away on their own.

Rarely, Stelara may cause some serious side effects. Contact your doctor if you experience:

Get emergency medical help right away if you experience:

  • symptoms of a serious allergic reaction, such as:
    • trouble breathing
    • chest tightness
    • swelling in your face, eyelids, tongue, or throat
  • symptoms of reversible posterior leukoencephalopathy syndrome (RPLS), such as:
    • sudden confusion
    • vision problems

If you’d like to learn more about Stelara, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.

Note: For more information on the conditions that Stelara is used to treat, refer to the following on Medical News Today:

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 other 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.