Stelara (ustekinumab) is a brand-name injection prescribed for certain inflammatory conditions, such as plaque psoriasis. As with other drugs, Stelara can cause side effects. Three common side effects of the drug are headache, fatigue, and infections.

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”)
  • headache
  • discoloration at the injection site
  • nausea
  • upper respiratory infections, such as the common cold, bronchitis, and 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 prescribing information.

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 during Stelara treatment and want to tell the FDA about it, visit MedWatch.

Though rare, Stelara may cause serious side effects. Serious side effects weren’t common in clinical trials. The list that follows may not include all possible reported serious side effects of the drug. For more information, you can refer to the Stelara prescribing information.

If you develop serious side effects while receiving 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” 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 receiving Stelara.

In a clinical trial of Stelara for adults with plaque psoriasis, a small percentage of people receiving Stelara reported depression as a side effect. A few people receiving a placebo (a treatment without an active ingredient) also reported depression as a side effect.

Some symptoms of depression and anxiety can overlap. These symptoms include fatigue, difficulty concentrating or thinking, and feeling restless or on edge. Also, fatigue is a commonly reported 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 during Stelara treatment, talk with your doctor. They can 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 should not cause side effects.

However, if you stop Stelara treatment, the condition you’re receiving 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 should not stop receiving 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 receiving 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 receiving Stelara. They can help identify possible causes. They can also recommend whether you should take any actions to help maintain a weight that’s healthy for you.

Is hair loss one of Stelara’s side effects?

In clinical trials, people receiving 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 this condition.

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.

What are the long-term side effects of Stelara?

Long-term side effects include those that may start at any time you’re taking a drug, even if you’ve taken it for a long time. They also include side effects that may not go away, even after you stop taking the drug.

Examples of long-term side effects reported in Stelara’s clinical trials and after the drug became available on the market include:

  • cancer
  • serious infections
  • noninfectious pneumonia

However, long-term side effects of Stelara are rare.

If you’re concerned about long-term side effects from Stelara, talk with your doctor. They can discuss with you possible long-term side effects of Stelara, what symptoms to watch for, and how long they may last. They’ll also let you know whether the benefits of taking the medication outweigh the risk of long-term side effects for your situation.

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

Posterior reversible encephalopathy syndrome

Posterior reversible leukoencephalopathy syndrome (PRES) is a very rare but serious side effect reported in clinical trials of Stelara. PRES is also known as reversible posterior leukoencephalopathy syndrome.

PRES 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

PRES in people receiving Stelara is rare. However, it’s important to note that PRES can be fatal if it isn’t treated quickly. With stopping Stelara and fast treatment, there usually aren’t long-term effects from PRES.

It isn’t known why Stelara can cause PRES. Other medications, such as cyclosporine, can also cause PRES 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 PRES 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 low 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. However, it occurred in only a small percentage of people receiving the drug in clinical trials. Almost as many people receiving a placebo (a treatment without an active ingredient) in trials also reported fatigue.

What you can do

Fatigue often goes away after a few days or weeks of Stelara treatment. 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 caused muscle pain in rare instances, but joint pain was not reported. A small number of people receiving a placebo (a treatment without an active ingredient) 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 receiving 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

Stelara may increase your risk of 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 Stelara are rare. In clinical trials, some serious infections required treatment in the hospital.

Serious infections reported in people receiving Stelara in clinical trials include:

During Stelara treatment, your doctor will monitor you for symptoms of TB and 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 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 have a risk of 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 receiving 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 during Stelara treatment. Your doctor may want to examine you if you have any of the symptoms listed in the preceding section. 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 of 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 of nonmelanoma skin cancer while receiving 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 is needed to know 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 receiving Stelara in clinical trials. These cancers also occurred in about equal numbers of people receiving a placebo (a treatment without an active ingredient) in these trials.

In clinical trials of Stelara for treating Crohn’s disease and ulcerative colitis, rates of new cancers were very low. As a result, the researchers couldn’t come to any conclusions about whether the drug contributed to cancer development.

Symptoms of cancer may include:

  • unexplained weight loss
  • fatigue
  • cough
  • skin changes

What you can do

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

Allergic reaction

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

Symptoms can be mild or serious and can include:

  • rash
  • itching
  • flushing
  • 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 using 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 start 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 of serious infections. If you’ve had certain infections in the past, 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 receiving 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, which you should not get during Stelara treatment. Live vaccines contain a small amount of a live bacterium 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 of developing cancer. The drug works by decreasing the activity of your immune system. This may prevent your immune system from killing cancer cells or stopping cancer cells from spreading.

Before starting Stelara, talk with your doctor about any history of cancer you may have. They can determine whether Stelara is safe for you to use.

Allergic reaction: You should not receive 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 should not 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 during Stelara treatment.

Pregnancy and breastfeeding while receiving Stelara

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

Stelara is approved to treat the following in certain inflammatory conditions, such as plaque psoriasis.

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.

Though rare, 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:
    • difficulty breathing
    • chest tightness
    • swelling in your face, eyelids, tongue, or throat
  • symptoms of posterior reversible encephalopathy syndrome (PRES), such as:

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 receiving 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 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.