Stelara (ustekinumab) is an injectable medication that treats psoriasis and psoriatic arthritis in adults and children ages 6 and older. It also treats inflammatory bowel disease (IBD) in adults.
Common Stelara side effects include headaches, fatigue, and a higher risk of infections. Diarrhea, nausea, and muscle or joint pain are also possible. Injection site reactions can happen where you inject Stelara.
Rare Stelara side effects include a higher risk of serious infections and skin cancer. You may also develop antibodies that make Stelara less effective over time.
Autoimmune conditions such as psoriasis, psoriatic arthritis, and inflammatory bowel disease (IBD) all have one thing in common: inflammation. And if it gets too severe, your prescriber may suggest a medication like Stelara (ustekinumab) to help manage your condition.
Stelara is FDA approved for adults, and it’s also approved for children ages 6 and over with certain conditions. It’s an injectable medication, but you’ll only need injections 4 to 6 times a year after your first dose or two. Even though you don’t inject it often, Stelara can still cause side effects you should be aware of.
Below are lists of mild and serious Stelara side effects that can happen during treatment. Keep in mind that other side effects are possible. So be sure to discuss any concerning side effects with your healthcare team.
Mild Stelara side effects include:
Common cold symptoms, such as a runny nose, cough, or sore throat
Upper respiratory infections
Injection site reactions
Headaches
Fatigue
Diarrhea or stomach pain
Back, muscle, or joint pain
Nausea
Dizziness
Vaginal yeast infections
Urinary tract infections
Itching
Depression
Serious Stelara side effects include:
Increased risk of serious infections, such as pneumonia or sepsis
Lung inflammation
Higher risk of skin cancer
Antibodies to Stelara, which can lead to medication resistance
In addition to the above side effects, Stelara can also cause severe allergic reactions. While not common, an allergic reaction can be an emergency if it occurs.
Let’s take a closer look at nine Stelara side effects and what you can do to help manage them.
Stelara reduces inflammation by blocking proteins in your immune system called interleukins. While this helps manage autoimmune diseases, it can also lower your immune system’s ability to fight off infections. As a result, you have a higher risk of infections while you’re being treated with Stelara. This risk can include mild infections, such as the common cold, as well as serious infections, such as pneumonia. Urinary tract and vaginal yeast infections are also possible, but they’re more common if you’re receiving Stelara for Crohn’s disease.
Although rare, Stelara can also reactivate a tuberculosis (TB) infection if you’ve had TB before or carry the bacteria in your body (latent TB). Before your first dose of Stelara, your prescriber may test you for TB and other infections. They’ll also let you know if you’re due for any vaccines before starting Stelara to help protect you from certain infections.
Keep an eye out for any signs of infection while you’re receiving Stelara. These include:
Fever
Persistent cough
Sore throat
Muscle aches
Pain or burning while peeing or a need to pee more often than usual
Vaginal itching and/or foul-smelling discharge
Severe fatigue
Trouble breathing
Warm, red, or painful skin
Stelara (ustekinumab) dosages: Learn more about recommended Stelara dosages by health condition and how often you’ll receive the medication.
How to inject Stelara: Follow these step-by-step instructions to help you inject Stelara safely.
Skyrizi (risankizumab) vs. Stelara: Here’s how these two psoriasis treatments compare.
Contact your healthcare team if you develop any signs or symptoms of an infection. In some cases, they may have you hold off on your next Stelara dose until you feel better.
Headaches are another common Stelara side effect. While they often resolve on their own, there are steps you can take to help manage or prevent headaches, including:
Limiting caffeine, alcohol, and artificial sweeteners
Managing stress
If needed, you can also try over-the-counter (OTC) pain relievers such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil). Just check with your prescriber or pharmacist first. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, aren’t always recommended for people living with IBD.
Good to know: In very rare cases, Stelara may cause a serious side effect called posterior reversible encephalopathy syndrome, or PRES. It causes the brain to swell, leading to a headache along with confusion, vision problems, or seizures. If you have a headache along with any of these symptoms, seek emergency care immediately.
Feeling tired or run-down is another common Stelara side effect. As with headaches, lifestyle modifications, such as staying hydrated and getting enough sleep, may help. Exercise can also boost your energy levels. But sometimes, your best bet is to take it easy for a day or two after your Stelara injection to let the fatigue run its course. Do what feels right for you.
If you have fatigue that becomes bothersome, let your prescriber know. It could be a sign of infection or something else going on. Your healthcare team can help figure out the cause and how best to manage it.
Diarrhea is another possible side effect of Stelara. It was reported more by people living with ulcerative colitis in clinical studies. Since ulcerative colitis can also cause diarrhea, it’s unclear how much Stelara itself contributes to this symptom.
Diarrhea can be a symptom of some infections and, as mentioned, Stelara can raise your risk for infections. So if you develop diarrhea while taking Stelara, it’s best to let your healthcare team know — especially if you also have stomach pain, fever, or other infection-related symptoms.
An OTC diarrhea medication such as loperamide (Imodium A-D) may help lessen diarrhea if your prescriber OKs it. Dehydration is a risk with diarrhea, so do your best to drink plenty of liquids, too.
Since Stelara is an injectable medication, it may cause injection site reactions. These reactions can include pain, itching, and swelling in the area where you inject it.
You can help ease discomfort by applying a warm or cold compress to the irritated area. An OTC pain medication can also help.
These reactions generally go away within a few days after the injection. To reduce your risk of developing an injection site reaction, be sure to follow the directions for injecting Stelara carefully. If pain, swelling, or redness worsens, it could be a sign of infection. So be sure to let your prescriber know if you have an injection site reaction that doesn't improve or worsens.
Like many other medications, Stelara may cause nausea. This can be unpleasant, but it’s usually not serious and often goes away on its own. You can try managing nausea on your own by:
Avoiding spicy or fried foods
Eating smaller, more frequent meals
Trying ginger or peppermint lozenges
Talk with your healthcare team if you have nausea that persists or gets worse. They may recommend an OTC or prescription nausea medication. They may also suggest taking one of these medications before you inject Stelara to help prevent nausea.
Good to know: It’s unlikely that nausea will lead to vomiting after a Stelara injection. But vomiting is common after the one-time infusion of Stelara, which is the first dose for Crohn’s disease. Your healthcare team may give you medication before the infusion to help.
Sometimes, Stelara can cause muscle or joint pain. Back pain was also a common Stelara side effect reported in clinical studies. These side effects were reported more often with Stelara treatment for psoriasis and psoriatic arthritis.
If you develop pain after receiving Stelara, an OTC pain medication may help. Just be sure to get your prescriber or pharmacist’s OK first. A heating pad, ice, or gentle stretching may also help. You should report any severe or worsening pain to your prescriber.
Keep in mind that body aches may also be a sign of infection. So keep an eye out for other symptoms of infection and let your prescriber know if they appear.
Stelara can increase your risk of developing nonmelanoma skin cancer. The risk of cancer is higher if you also have other contributing factors, such as a personal or family history of skin cancer or light-colored skin. To lower your risk of skin cancer, always use sunscreen with an SPF of 30 or higher and/or other forms of sun protection while outdoors.
The most common sign of skin cancer is a change in an existing mole or a new growth or sore that won’t heal. Your prescriber will likely monitor your skin while you’re using Stelara. But if you notice any skin changes on your own, don’t hesitate to contact them. Skin cancer is highly curable when caught early.
Biologic medications, including Stelara, are made from living organisms. Because of this, when you inject Stelara, your body may think the medication is a foreign invader (like bacteria) and try to fight it off. If this occurs, your body can develop antibodies against Stelara. These “anti-drug antibodies” can make Stelara less effective over time.
If you feel like Stelara isn’t working as well as it used to, you may be developing antibodies against it. Let your prescriber know if Stelara seems less effective at any point. They can test for antibodies and switch you to another medication if needed.
Weight gain isn’t considered a common Stelara side effect. It wasn’t reported in the initial clinical studies of the medication. But there is some later evidence that shows weight gain may occur in some people receiving Stelara.
Keep in mind that the conditions Stelara treats may also lead to weight gain in some cases. Focusing on a balanced diet and regular exercise can help you manage your weight. But be sure to let your prescriber know if your weight changes significantly while receiving Stelara. They can help you determine the cause as well as the best steps for you to take.
Yes, both Stelara and the conditions it treats can contribute to feelings of depression in some people. But Stelara may also help improve feelings of anxiety and depression as the symptoms of your condition improve.
If you notice that you’re feeling down more often or you’re less interested in daily activities while receiving Stelara, talk to your healthcare team for guidance.
Weight gain isn’t considered a common Stelara side effect. It wasn’t reported in the initial clinical studies of the medication. But there is some later evidence that shows weight gain may occur in some people receiving Stelara.
Keep in mind that the conditions Stelara treats may also lead to weight gain in some cases. Focusing on a balanced diet and regular exercise can help you manage your weight. But be sure to let your prescriber know if your weight changes significantly while receiving Stelara. They can help you determine the cause as well as the best steps for you to take.
Yes, both Stelara and the conditions it treats can contribute to feelings of depression in some people. But Stelara may also help improve feelings of anxiety and depression as the symptoms of your condition improve.
If you notice that you’re feeling down more often or you’re less interested in daily activities while receiving Stelara, talk to your healthcare team for guidance.
Common Stelara (ustekinumab) side effects include infections, headaches, and fatigue. Diarrhea, nausea, and muscle or joint pain are also possible. Injection site reactions can also happen after receiving Stelara. Rare Stelara side effects include a higher risk of skin cancer and severe infections and the development of anti-drug antibodies.
You should let your prescriber know if you develop any signs of infection or experience side effects that don’t resolve on their own. Seek emergency care for any Stelara side effects that seem severe or life-threatening.
Araniti, G. (2024). Autoimmune diseases and their effects on metabolism and weight. Immunological Disorders and Immunotherapy.
Centers for Disease Control and Prevention. (2024). Skin cancer risk factors.
Drexler, M. (2010). How infection works. What You Need to Know About Infectious Disease. National Academies Press.
Janssen Biotech. (2022). Stelara - ustekinumab injection, solution; Stelara - ustekinumab solution [package insert].
Justiz Vaillant, A. A., et al. (2022). Interleukin. StatPearls.
Langley, R. G., et al. (2010). Ustekinumab significantly improves symptoms of anxiety, depression, and skin-related quality of life in patients with moderate-to-severe psoriasis: Results from a randomized, double-blind, placebo-controlled phase III trial. Journal of the American Academy of Dermatology.
Owczarczyk-Saczonek, A., et al. (2014). Influence of ustekinumab on body weight of patients with psoriasis: An initial report. Advances in Dermatology and Allergology.
Pizano-Martinez, O., et al. (2023). Anti-drug antibodies in the biological therapy of autoimmune rheumatic diseases. Journal of Clinical Medicine.
Triplett, J. D., et al. (2022). Posterior reversible encephalopathy syndrome (PRES): Diagnosis and management. Practical Neurology.
Zelaya, J. E., et al. (2024). Posterior reversible encephalopathy syndrome. StatPearls.