Spesolimab Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 12, 2024.

Applies to spesolimab: intravenous solution.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness. These may be signs that you have an infection.

This medicine may cause serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, or skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

Serious skin reaction, including drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

While you are being treated with spesolimab-sbzo, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given with spesolimab-sbzo.

Serious side effects of spesolimab

Along with its needed effects, spesolimab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking spesolimab:

Other side effects of spesolimab

Some side effects of spesolimab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to spesolimab: intravenous solution, subcutaneous solution.

General adverse events

The most common adverse effects were infections. Infection occurred in 14% of patients during the first week of treatment as compared to 6% in the placebo group. The majority of infections reported were mild (29%) to moderate (71%).^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (11%)
• Common (1% to 10%): Gastritis, nausea and vomiting, oral herpes^[Ref]

Dermatologic

• Common (1% to 10%): Cellulitis, furuncle, herpes dermatitis, pruritus and prurigo, subcutaneous abscess, urticaria^[Ref]

Two patients experienced drug reaction with eosinophilia and systemic symptoms (DRESS). The validation scoring for reported cases were "no DRESS" and "possible DRESS".^[Ref]

Genitourinary

• Common (1% to 10%): Bacteriuria, urinary tract infection, vulvovaginal candidiasis, vulvovaginal mycotic infection^[Ref]

Local

• Common (1% to 10%): Infusion site hematoma and bruising

Not reported: Injection site reactions^[Ref]

During clinical trials, injection site reactions (including injection site erythema, injection site swelling, injection site pain, injection site induration, and injection site warmth) were observed.^[Ref]

Nervous system

• Common (1% to 10%): Headache
• Uncommon (0.1% to 1%): Guillain-Barre syndrome^[Ref]

Ocular

• Common (1% to 10%): Eye edema^[Ref]

Other

• Common (1% to 10%): Asthenia and fatigue, bacteremia, device-related infection, otitis externa^[Ref]

Respiratory

• Common (1% to 10%): Dyspnea, influenza, latent tuberculosis, upper respiratory tract infection^[Ref]

See also:

Further information

Spesolimab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer