What are 7 key Stelara side effects to watch out for?

Key Points

• Stelara (ustekinumab) is a monoclonal antibody that may be used to treat certain inflammatory conditions such as psoriasis and ulcerative colitis.
• Common side effects of Stelara include nasopharyngitis, infections, nausea, and injection site reactions.
• More serious but rare side effects of Stelara are severe allergic reactions, posterior reversible encephalopathy syndrome (PRES), and a potentially higher risk of cancer.

What is Stelara?

Stelara (ustekinumab) is an interleukin antagonist that may be used to treat certain inflammatory conditions. It is FDA approved to treat adults with psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It is also approved in children 6 years and older with psoriasis and psoriatic arthritis.

Stelara comes as an injection that may be given intravenously (into the vein) or subcutaneously (under the skin). It’s injected every 8-12 weeks depending on the reason it’s being used.

7 side effects of Stelara and how to manage them

Below, we’ll review 7 side effects* of Stelara that you should watch out for. Many side effects can be treated at home, and most should not last long. We’ll also offer a few tips on how to cope with side effects you may experience while taking Stelara.

1. Injection site reactions

Because Stelara is injected into your body, you may experience injection site reactions after your dose. These can include pain, swelling, itching, a hard lump, bruising, bleeding, and irritation around the area where Stelara is injected. It may take a few days before the area clears up and feels better.

Tips for managing injection site reactions

• Consider taking an over-the-counter pain reliever like ibuprofen (Advil) or acetaminophen (Tylenol)
• Apply an ice pack for 10 minutes to decrease swelling
• Do not wear tight-fitted clothing around the injection site

If you notice that your symptoms are getting worse, or if they are not getting better within a few days, contact your healthcare provider. They can check to make sure the area is not infected and recommend appropriate treatment options to help you heal.

2. Infections

Part of the way Stelara works to lower inflammation is by changing the body’s immune response. It blocks the actions of two signaling chemicals called interleukin-12 and interleukin-23. These chemicals are involved in activating the immune system. By blocking them, your immune system might not be able to fight off infections as well while you are taking Stelara.

In early studies, more people taking Stelara reported more infections such as the common cold, vaginal yeast infection, sinus infection, urinary tract infection, and dental infection than those taking a placebo (no active medication). Other infections reported during studies include upper respiratory tract infections, skin infections, pneumonia, listeriosis, and sepsis. However, in a long-term safety study, researchers did not find a meaningful difference between the infection rate of people taking Stelara compared to people taking a placebo.

Stelara may raise your risk for reactivation of previous infections that are not active in your body. Tell your healthcare provider if you have any signs or symptoms of an infection, including:

• Fever
• Chills
• Weight loss
• Cough
• Diarrhea
• Stomach pain
• Burning during urination
• Feeling more tired than usual
• Trouble breathing

If you have an infection, your healthcare provider might recommend pausing your treatment with Stelara until you get better. Before starting treatment with Stelara, it is recommended to get up to date with all of your vaccines.

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3. Headache

Headache is a common side effect of Stelara, affecting up to 10% of people who take it. While it isn’t clear why Stelara might cause headaches, there are some things you can try at home to get some relief.

Tips for managing headache

• Take an over-the-counter pain reliever
• Create a quiet environment
• Rest in a dark room
• Stay hydrated
• Practice relaxation techniques
• Apply a warm or cool compress to your forehead

Contact your prescriber if your headache seems severe, is not going away, or if you are also having visual disturbances. Headache is a symptom of a rare condition called posterior reversible encephalopathy syndrome (PRES), which some people reported during clinical trials of Stelara.

4. Severe allergic reaction

Although rare, Stelara can cause a severe allergic reaction in some people. Watch out for symptoms of an allergic reaction, including:

• Difficulty breathing
• Tightness in the throat
• Flushing
• Chest discomfort
• Hives
• Fever
• Swelling

Get medical help right away if you experience signs of an allergic reaction.

5. Nausea and vomiting

Nausea and vomiting are potential side effects of Stelara. In clinical trials, more people taking Stelara for Crohn’s disease and psoriatic arthritis reported nausea compared to those taking a placebo. While not everyone will experience nausea or vomiting, it’s good to know what to do if it happens to you.

Tips for managing nausea and vomiting

• Try ginger chews or tea, or peppermint tea
• Eat smaller meals throughout the day
• Eat bland foods and avoid spicy or greasy foods
• Eat more slowly
• Drink plenty of fluids to stay hydrated
• Do not lay down right away after eating

Sometimes, nausea and vomiting can be a sign of an infection or more serious medical problem. If it seems severe or is not getting better, call your healthcare provider for further guidance.

6. Fatigue

Stelara can cause you to feel more tired than usual. It can be difficult to know if your medication is causing you to feel fatigued, or if it’s due to another reason. In clinical trials, more people taking Stelara for ulcerative colitis and psoriasis reported fatigue as a side effect compared to people taking a placebo.

Tips for managing fatigue

• Practice good sleep hygiene and aim for 8 hours of sleep at night
• Rest or take short naps during the day
• Choose foods that give you energy
• Eat a balanced diet

Tell your healthcare provider if you feel so tired that it is affecting your normal daily activities.

7. Risk of cancer

Because Stelara weakens the immune system, it might raise your risk for cancer. Rarely, some people taking Stelara during clinical trials reported certain cancers. One cancer reported with Stelara was non-melanoma skin cancer. Other cancers reported include prostate cancer, breast cancer, and colorectal cancer.

Make sure to get your skin checked regularly for abnormalities and wear protective clothing and sunscreen when spending time in the sun. Discuss your risk for cancer with your healthcare provider.

* This is not a complete list of side effects. See here for more information.