9 Stelara Side Effects You Should Know About

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 healthcare provider may suggest a medication like Stelara (ustekinumab) to help manage your condition.

Stelara is approved for adults, and it’s also approved for children ages 6 and over for 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.

Stelara side effects at a glance

Both mild and serious side effects are possible with Stelara.  

Mild side effects: 

• Common cold symptoms, such as a runny nose, cough, or sore throat

• Injection site reactions

• Headache

• Fatigue

• Diarrhea or stomach pain

• Back, muscle or joint pain

• Nausea

• Dizziness

• Vaginal yeast infection

• Urinary tract infection

• Itching

Serious side effects:

• Severe allergic reaction

• Serious infections, such as pneumonia or sepsis

• Lung inflammation

• Posterior reversible encephalopathy syndrome

• Higher risk of skin cancer

• Antibodies to Stelara

Let’s take a closer look at nine Stelara side effects and what you can do to help manage them. 

1. Increased risk of infections

Stelara reduces inflammation by blocking proteins in your immune system called interleukins. While this helps manage your autoimmune disease, 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 can range from mild infections, such as the common cold, to serious infections, such as pneumonia. Urinary tract and vaginal infections are also possible, but they’re more common if Stelara is prescribed for Crohn’s disease.

Although rare, Stelara can also reactivate a tuberculosis (TB) infection if you’ve had it before or carry the bacteria in your body (latent TB). Before your first dose of Stelara, your healthcare provider may test you for TB and other infections. They’ll also let you know if you’re due for any vaccines.

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 discharge

• Fatigue

• Trouble breathing

• Warm, red, or painful skin

Contact your provider if you develop any symptoms of an infection. In some cases, they may have you hold off on your next Stelara dose until you feel better.

2. Headache

Headaches are another common Stelara side effect. They often resolve on their own, but there are steps you can take to help manage or prevent headaches, including:

• Limiting caffeine, alcohol, and artificial sweeteners

• Staying hydrated

• Getting enough sleep

• 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 provider first. Nonsteroidal anti-inflammatory (NSAIDs), such as ibuprofen, aren’t always recommended for those with IBD.

Good to know: In very rare cases, Stelara may cause a serious side effect called posterior reversible encephalopathy syndrome (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.

3. Fatigue

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 fatigue run its course. Do what feels right for you.

If fatigue becomes bothersome, let your provider know. It could be a sign of infection or something else going on. Your provider can help figure out the cause and how best to manage it. 

4. Diarrhea

Diarrhea is another possible side effect of Stelara. It was reported more by people with ulcerative colitis in clinical studies. This condition can also cause diarrhea, so it’s unclear how much Stelara itself contributes to this side effect.

But Stelara can raise your risk for infections, and diarrhea can be a symptom of some infections. So if you develop diarrhea while taking Stelara, it’s best to let your healthcare provider 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 provider OKs it. Dehydration is another risk of diarrhea, so do your best to drink plenty of liquids, too.

5. Injection-site reactions

Since Stelara is an injectable medication, it may cause injection-site reactions. These include pain, itching, and swelling in the area where you inject it.

You can ease discomfort by applying a warm or cold compress to the area. An OTC pain medication can also help.

These reactions generally go away within a few days of 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 worsen, it could be a sign of infection. So be sure to let your provider know if an injection-site reaction doesn't improve or worsens.

6. Nausea

Like many other medications, Stelara may cause nausea. Nausea can be unpleasant, but it’s usually not serious and often goes away on its own. You can try managing it on your own by:

• Avoiding spicy or fried foods

• Eating smaller, more frequent meals

• Trying ginger or peppermint lozenges

Talk with your healthcare provider if nausea persists or gets worse. They may recommend an OTC or prescription nausea medication. They may also suggest taking one of these 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 provider may give you medication before the infusion to help.   

7. Muscle or joint pain

Sometimes, Stelara can cause muscle or joint pain. Back pain was also a common Stelara side effect in clinical studies. These side effects were reported more often with Stelara treatment for psoriasis and psoriatic arthritis.

You should report any new or worsening pain to your provider. Keep in mind that body aches may also be a sign of infection. So keep an eye out for any other infection symptoms and let your provider know if they appear.

OTC pain medication may help. Just be sure to get your provider or pharmacist’s OK first. A heating pad, ice, or gentle stretching may also help. 

8. Increased risk of skin cancer

Stelara can increase your risk of developing non-melanoma skin cancer. The risk is higher if you also have other risk factors, such as a personal or family history of skin cancer or light-colored skin. To lower your risk, always use sunscreen while outdoors.

The most common signs of skin cancer are a change in an existing mole or a new growth or sore that won’t heal. Your healthcare provider 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.

9. Anti-drug antibodies

Biologic medications like Stelara are made from a living organism. Because of this, when you inject Stelara, your body may think it’s 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 provider know if Stelara seems less effective at any point. They can test for antibodies and switch you to another medication if needed.

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Written by:

Emilie White, PharmD

Emilie White is a clinical pharmacist with over a decade of hospital pharmacy experience. Her professional areas of interest include critical care as well as infectious and autoimmune diseases.

Edited by:

Stacia Woodcock, PharmD

Stacia Woodcock, PharmD, is a pharmacy editor for GoodRx. She earned her Doctor of Pharmacy degree from the University of Kentucky and is licensed in New York and Massachusetts.

Reviewed by:

Daphne Berryhill, RPh

Daphne Berryhill, RPh, has two decades of experience as a clinical pharmacist. She spent most of her career in the Chicago area practicing in-home infusion.

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