September 7, 2022

Stelara: Overview, Side Effects and More

Specialty Infusion Blog Elan Katz

Stelara, or ustekinumab, is a biological drug used to treat adults and children aged six and older with mild to severe plaque psoriasis, adults with moderate-to-severe psoriatic arthritis, and adults with moderate-to-severe Crohn’s disease and ulcerative colitis by reducing inflammation. After previous drugs have failed to work, this one is administered as an injection at home. IL-12 and IL-23, two inflammatory proteins, are blocked by Stelara, but a  biological drug like this might take many months to start functioning. Long-term use of biologics is also common.

Stelara is indicated for treating plaque psoriasis and psoriatic arthritis—or both conditions—in adults and children who are at least six years old. Individuals with mild to highly active Crohn’s disease who have failed to respond to prior medications are prescribed Stelara, as are Adults who have moderately to severely active ulcerative colitis.

How to use Stelara

Injections of Stelara are given first, then again four weeks later, and every 12 weeks after that. In Crohn’s disease, it is administered as an injection under the skin, although it may first be administered as an infusion in the vein. Individuals under 100 kg (220 lbs.) get a 45 mg dosage, while those who weigh more than 100 kg receive a 90 mg dose. To lower the chance of infection, you must have a TB screening test before beginning this medicine. While using this drug, patients must see their doctor often for checkups.

Side effects of Stelara

Common Side Effects of Stelara

  • The common side effects appear when Stelara is injected; at the injection site, there can be bruising, itchiness, discomfort, redness, swelling, or skin hardening.
  • Reactions at the injection site often subside within one or two days. Back discomfort, sinus/throat pain, or headaches may also occur. Inform your doctor or pharmacist as soon as possible if any of these side effects persist or become worse.
  • This drug might impact the immune system. Your body’s capacity to fight an infection may be diminished. You may be more prone to severe conditions, like lung infections, bone/joint infections, skin infections, sinus infections, or bowel/gallbladder infections.
  • Additionally, fighting an illness you already have may be more difficult. If you develop any signs of disease, you must immediately consult your healthcare professional. Symptoms include nausea/vomiting that doesn’t stop, painful/frequent urination, aggravated tenderness and swelling, redness at the injection site after two days, fever/chills, cold/flu symptoms, unusual vaginal discharge, burning, itching, odor, or severe pain in the stomach.
  • Remember that your doctor has recommended this medicine because they believe it will help you more than harm you—many users of this medicine report no significant adverse effects.
  • Call your pharmacist and doctor immediately in the case of severe side effects, such as a cough that won’t go away or shortness of breath.

Serious Side Effects of Stelara

Stelara may result in PRES (posterior reversible encephalopathy syndrome), an uncommon (and sometimes deadly) disease. If you get a headache that won’t go away, seizures, abrupt eyesight changes, or mental/mood abnormalities, seek medical attention immediately.

With the use of Stelara, there is a minimal chance that you may get cancer, such as skin cancer. Consult your doctor about the advantages and disadvantages of the proposed course of therapy.

Call your healthcare professional immediately if you have symptoms like strange lumps or growths, unexpected skin changes, swollen glands, or unusual weight loss.

Effect of other drugs on Stelara

Stelara may interact with other medications, such as over-the-counter drugs, prescription drugs, supplements like vitamins, and herbal medicines. Inform your doctor about your existing medications and any new or discontinued ones.

Before starting Stelara, consult your doctor

Stelara could weaken your immune system and raise your chance of developing various infections. Some people using Stelara get severe infections like tuberculosis (TB) and infections brought on by bacteria, fungi, or viruses, which may need hospitalization.

Before beginning the Stelara medication, your doctor should test you for TB. They should also keep a careful eye out for any TB symptoms while you are on Stelara.

If your doctor believes you are at risk of TB, you could get TB therapy before and after taking Stelara.

If you are suffering from any infection, you must not take Stelara until your doctor gives the all-clear.

Before initiating Stelara, you must consult with your doctor if you have the following symptoms:

  • Red or painful skin
  • Cough
  • Shortness of breath
  • Blood in phlegm
  • Tiredness
  • Stomach pain or diarrhea
  • Weight loss
  • Urination problems

Warnings and precautions for Stelara


Never start Stelara when there is a clinically significant active infection. Consider stopping Stelara until the infection clears up if a major infection or clinically significant infection develops.

Theoretical Risk of Specific Infections: 

Patients with hereditary IL-12/IL-23 deficiency have been linked to severe infections from mycobacteria, salmonella, and BCG vaccines. Consider diagnostic testing for these infections as warranted by the clinical situation. Before beginning Stelara medication, people with tuberculosis (TB) should be tested for the disease. Before giving Stelara, begin latent TB therapy.


The chances of cancer development increase with the use of Stelara. Its safety in individuals with a history of or currently being treated for malignancy has not been examined.

Anaphylaxis or other clinically severe hypersensitivity events might happen.

If you suspect PRES, get treatment at once and stop taking Stelara.

Noninfectious Pneumonia: 

During post-approval use of Stelara, cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported. If the diagnosis is validated, stop taking Stelara and start the appropriate therapy.