Key Takeaways
- Stelara is a prescription injection used to treat autoimmune conditions, including plaque psoriasis and psoriatic arthritis.
- Common side effects of Stelara include infections (like the common cold), headache, and fatigue. But the drug’s common side effects can vary based on the condition being treated.
- Serious side effects are rare but can occur. These include serious infections, cancer, and a brain condition called posterior reversible encephalopathy syndrome.
Stelara (ustekinumab) is used in adults to treat:
It can also be used to treat plaque psoriasis and psoriatic arthritis in certain children.
Keep reading to learn about the common, mild, and serious side effects (also called adverse effects) that Stelara can cause.
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:
- infections, such as the common cold
- headache
- fatigue
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:
- the common cold
More common side effects 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
To learn more about some of these side effects, see the “Side effects explained” section.
* 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:
- infections, such as the common cold
- headache
- fatigue
- muscle or joint pain
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 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 some of these side effects, see the “Side effects explained” section.
* 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 previously. See the Stelara prescribing information for details.
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 medication safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect during treatment with Stelara and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.
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:
- serious infections, such as tuberculosis (TB)
- pneumonia, either infectious or noninfectious*
- lung inflammation (swollen and irritated lungs)
- cancer, such as skin cancer
- posterior reversible encephalopathy syndrome, a brain condition
* Noninfectious pneumonia was not reported in studies of Stelara. But this side effect was reported after the drug became available for use.
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.
Allergic reactionStelara can cause an allergic reaction in some people. Allergic reaction was a rare side effect reported in studies of Stelara. And since the drug became available for use, there have been additional reports of allergic reactions with symptoms such as skin rash or hives.
Stelara also has latex in the needle cover of one of the forms it comes in, the prefilled syringe. You should not handle the needle cover if you’re sensitive to latex. If you have a latex allergy, talk with your doctor before starting Stelara treatment.
In general, symptoms of an allergic reaction can be mild or serious.
What might helpIf you have mild symptoms of an allergic reaction, such as a mild skin rash or hives, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should continue Stelara treatment.
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’ve had a serious allergic reaction to Stelara, they may have you switch to a different treatment.
It’s possible 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 end your Stelara treatment. 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.
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:
- loss of interest in activities that you usually enjoy
- difficulty sleeping or sleeping more than usual
- changes in appetite
- irritability
If you have any symptoms of depression, anxiety, or 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.
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 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).
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:
- the common cold
- yeast infection
- bronchitis
- urinary tract infection (UTI)
- sinus infection
- flu
During treatment with Stelara, you should watch for symptoms of infection. Symptoms to look out for include:
- fever or chills
- cough
- shortness of breath
- warm, painful skin or body sores
- weight loss
- diarrhea or abdominal pain
- burning feeling when urinating
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 an infection.
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. Be sure to tell them if any of the following factors apply to you:
- active infections
- TB
- recent vaccinations
- allergic reaction to Stelara or any of its ingredients
- latex allergy
- cancer
- pregnancy
- breastfeeding
- alcohol consumption
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.