Stelara Side Effects

Key Takeaways

• • Stelara is a long-term treatment for multiple chronic inflammatory diseases like plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

• • Most people on Stelara experience mild symptoms like headaches or upper respiratory infections, which often resolve without stopping treatment.

• • IV induction doses for bowel conditions tend to produce more noticeable or systemic side effects compared to the lower, subcutaneous doses used in skin and joint diseases.

• • Stelara can increase the risk of serious infections because it dampens immune responses.

• • Rare cases of skin cancer and lymphoma have been reported, particularly in patients with additional risk factors or extended use, though a direct causal link remains uncertain.

• • Serious but rare neurological and respiratory conditions have been linked to Stelara.

What Is Stelara For?

Stelara (ustekinumab) is a prescription biologic medication approved by the FDA to treat several chronic inflammatory conditions, including:

• • Moderate to severe plaque psoriasis in adults and children aged 6 and older
  • Active psoriatic arthritis in adults and children aged 6 and older
  • Moderate to severe Crohn’s disease in adults
  • Moderate to severe ulcerative colitis in adults

Stelara helps reduce symptoms such as skin plaques, joint pain, and gastrointestinal inflammation by targeting specific proteins in the immune system (IL-12 and IL-23) that are involved in the inflammatory process.

It is available in pre-filled syringes and vials, and can be administered through subcutaneous injection or intravenous (IV) infusion, depending on the condition being treated.

Common Side Effects of Stelara

In clinical trials, Stelara has demonstrated a favorable safety profile, with most adverse events reported as mild and non-serious. The most commonly reported side effects are outlined below:

For Psoriasis and Psoriatic Arthritis

Stelara’s side effect profile is similar in patients with psoriasis and psoriatic arthritis. The following adverse events were reported in at least 3% of participants:

• • Upper respiratory tract infection, especially nasopharyngitis (common cold)
  • Headache
  • Fatigue

Since Stelara targets the immune system, mild infections or flu-like symptoms can occur as the body adjusts.

For Crohn’s Disease

If you’re using Stelara for Crohn’s disease, you may experience additional side effects, including:

• • Vomiting (during the initial dose)
  • Redness at the injection site
  • Mycotic infection, especially vaginal yeast infection
  • Bronchitis
  • Itching
  • Urinary tract infection (UTI)
  • Sinusitis

This is likely due to the induction phase of the treatment, where Stelara is administered intravenously (IV). This initial dose is typically higher than the subcutaneous doses used for psoriasis and psoriatic arthritis.

Induction doses range from 260 to 520 mg compared to subcutaneous maintenance doses of 45 to 90 mg. Higher doses can result in more pronounced immune modulation, which may increase susceptibility to infections and trigger temporary inflammatory reactions or mild allergic-like symptoms.

For Ulcerative Colitis

Stelara-treated patients with ulcerative colitis reported the following side effects during trials:

• • Nasopharyngitis
  • Headache
  • Abdominal pain
  • Influenza
  • Fever
  • Diarrhea
  • Sinusitis
  • Fatigue
  • Nausea

As with Crohn’s disease, ulcerative colitis treatment begins with an induction phase involving higher IV doses of Stelara. These larger doses may lead to more noticeable side effects early in treatment. Additionally, ulcerative colitis itself causes symptoms like abdominal pain and diarrhea, which may persist or even temporarily worsen during the initial adjustment period.

These effects are typically not serious and often resolve without discontinuing treatment. However, any persistent or worsening symptoms should be discussed with your healthcare provider.

Serious Side Effects of Stelara

Stelara can cause serious side effects, although they are uncommon. These include:

1. Serious Infections

Stelara can increase your risk of serious infections, not just the more common ones like vaginal yeast infections or upper respiratory tract infections. This happens because Stelara blocks certain proteins, interleukin-12 (IL-12) and interleukin-23 (IL-23), that are partly responsible for how your body fights off infections.

When your immune response is dampened, you may be more vulnerable to infections that can become severe if not caught early.

Here are some serious infections to be aware of:

• • Tuberculosis (TB): Even if you’ve never had symptoms, TB can be reactivated if it’s lying dormant in your body. That’s why your doctor will usually test you for TB before you start Stelara.

• • Opportunistic fungal infections: Stelara may increase your risk of infections like histoplasmosis, coccidioidomycosis, or pneumocystis pneumonia (PCP). These are rare, but can be dangerous if left untreated.

• • Serious bacterial or viral infections: These can spread quickly in your system and lead to hospitalization. Some examples include sepsis, shingles, or disseminated viral infections.

• • Urinary tract infections (UTIs): While often mild, UTIs can become serious if they reach your kidneys. Stelara might make it harder for your body to fight them off.

Here are the symptoms to watch for:

• • Fever, especially if it’s persistent, high, or comes with chills
  • Fatigue or weakness
  • Shortness of breath or difficulty breathing
  • Persistent cough
  • Unusual sweating, particularly night sweats
  • Nausea, vomiting, or diarrhea that doesn’t improve
  • Painful or frequent urination
  • Skin changes like rash, sores, or unusual bruising

2. Theoretical Risk for Specific Infections

There may be a theoretical risk of developing serious infections from certain bacteria, such as mycobacteria or salmonella, or live vaccines, such as Bacillus Calmette-Guerin (BCG, used for TB in some countries). However, the risks haven’t necessarily been observed often in clinical trials.

This is based on what doctors have observed in people born without IL-12 and IL-23, the same immune proteins that Stelara blocks.

Although these infections are not common in people taking Stelara, it’s still important to:

• • Let your doctor know if you’ve been exposed to TB or traveled to areas where BCG is used
  • Avoid live vaccines during treatment
  • Report any unusual or persistent symptoms

3. Cancer (Malignancies)

There have been rare reports of cancers in patients taking Stelara, including:

• • Skin cancers (e.g., basal cell carcinoma, squamous cell carcinoma)
  • Lymphoma
  • Prostate or colon cancer (noted in some long-term studies)

One case report described a 42-year-old man with Crohn’s disease who developed a rare and aggressive type of skin cancer known as achromatic malignant melanoma after three years of Stelara treatment.

He initially reported itching on his scalp, which led to a skin exam. Doctors found a melanoma without pigment, making it more difficult to detect. The cancer had already spread (metastasized) and tested positive for a BRAF gene mutation, a marker often seen in certain cancers.

While it’s not confirmed that Stelara directly causes these cancers, long-term immune suppression may slightly increase the risk, particularly in people with preexisting risk factors.

4. Posterior Reversible Encephalopathy Syndrome (PRES)

PRES, also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), is a rare but serious neurological condition that affects the brain. It causes sudden symptoms like:

• • Severe headache
  • Confusion or disorientation
  • Blurred vision, double vision, or even temporary vision loss
  • Seizures
  • Nausea or vomiting
  • Weakness or difficulty speaking (in some cases)

It involves swelling in the back (posterior) parts of the brain, usually in areas that control vision and awareness. This swelling happens because the blood vessels in the brain lose their ability to regulate pressure, leading to fluid leaking into brain tissue.

A case report describes an 18-year-old woman with a 6-year history of complicated Crohn’s disease who had been treated with multiple medications. Due to a poor response to previous treatments, she was switched to Stelara and received a 340 mg IV induction dose.

About 12 days later, she experienced a tonic-clonic seizure, which occurs when a person suddenly loses consciousness and the body goes through two phases:

• • Tonic phase – The body stiffens for a few seconds, and the person may fall if standing.

• • Clonic phase – The body then begins to jerk or shake rapidly and uncontrollably, usually lasting a minute or two.

An MRI of her brain showed signs consistent with PRES. No infection or serious electrolyte abnormalities were found.

Two cases were also reported during clinical trials, and additional cases have been seen after the drug was released, in patients with psoriasis, psoriatic arthritis, and Crohn’s disease.

5. Noninfectious Pneumonia

Noninfectious pneumonia is a type of lung inflammation that is not caused by bacteria, viruses, or fungi. Instead, it happens due to other triggers, such as medications, autoimmune diseases, or exposure to certain chemicals or irritants.

The symptoms can look just like infectious pneumonia:

• • Cough
  • Shortness of breath
  • Chest pain
  • Fatigue
  • Fever (sometimes)

Cases of lung inflammation, including interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia, have been reported in people using Stelara after it was approved for use.

A good rule of thumb:

If you feel unwell in a way that feels different, worse than usual, or doesn’t go away, contact your healthcare provider. See emergency care if symptoms are sudden, severe, or worsening quickly.

Summary

Stelara is used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It targets IL-12 and IL-23 proteins in the immune system to reduce inflammation and related symptoms.

While generally well-tolerated, Stelara can cause mild side effects such as upper respiratory infections, fatigue, and injection site reactions. More serious but rare risks include severe infections, certain cancers, noninfectious pneumonia, and neurological complications like PRES.

If you’re taking Stelara, report any unusual symptoms early, follow your doctor’s advice, and attend regular check-ups. This helps manage side effects and ensures the treatment is working effectively.

More Like This

These deep dives break down the side effect profiles of other commonly prescribed biologics:

• • Humira Side Effects – Find out what users report most often and why some switch due to tolerability concerns.

• • Side Effects of Enbrel – Get the facts on both common and rare reactions linked to long-term use.

• • Skyrizi Side Effects – See how this newer biologic measures up in terms of safety and reported patient experiences.

Explore these resources to help guide more informed conversations with your healthcare provider.

Frequently Asked Questions

Sources

Axiaris, G., Ioannou, A., Papoutsaki, M., Marinos, L., Liontos, M., Michopoulos, S., & Zampeli, E. (2023). Case Report: Malignant melanoma in a patient with Crohn’s disease treated with ustekinumab. F1000Research, 11, 424. https://doi.org/10.12688/f1000research.110356.2

Mishra, A., & Seril, D. N. (2018). Posterior Reversible Encephalopathy Syndrome following Ustekinumab Induction for Crohn’s Disease. Case reports in gastroenterology, 12(2), 521–527. https://doi.org/10.1159/000492462

Colquhoun, M., & Kemp, A. K. (2023, March 27). Ustekinumab. StatPearls – NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/books/NBK570645/

Janssen Pharmaceutical Companies. (2024). HIGHLIGHTS OF PRESCRIBING INFORMATION OF STELARA. https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf

Gisbert, J. P., Parody-Rúa, E., & Chaparro, M. (2023). Efficacy, effectiveness, and safety of ustekinumab for the treatment of ulcerative colitis: a systematic review. Inflammatory Bowel Diseases. https://doi.org/10.1093/ibd/izac275

Thomas, P. W. A., van Caem, M., West, R. L., Russel, M. G. V. M., Jansen, J. M., Römkens, T. E. H., Hoentjen, F., & IBDREAM registry (2023). Long-term effectiveness and safety of ustekinumab in Crohn’s disease: a prospective cohort study. European journal of gastroenterology & hepatology, 35(3), 261–269. https://doi.org/10.1097/MEG.0000000000002506