Rozanolixizumab Side Effects
Medically reviewed by Drugs.com. Last updated on Oct 29, 2024.
Applies to rozanolixizumab: subcutaneous solution.
Serious side effects of rozanolixizumab
Along with its needed effects, rozanolixizumab 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 rozanolixizumab:
More common side effects
- bladder pain
- bloody or cloudy urine
- body aches or pain
- burning or stinging of the skin
- chills
- cough
- difficult, burning, or painful urination
- ear congestion
- fast heartbeat
- fever
- frequent urge to urinate
- headache
- lower back or side pain
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- skin itching, rash, or redness
- sneezing
- sore throat
- stuffy or runny nose
- swelling of the face, throat, or tongue
- trouble breathing
- unusual tiredness or weakness
Other side effects of rozanolixizumab
Some side effects of rozanolixizumab 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:
More common side effects
- bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- diarrhea
- difficulty in moving
- joint pain
- muscle pain or stiffness
- stomach pain
For healthcare professionals
Applies to rozanolixizumab: subcutaneous solution.
General adverse events
Headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea were the prevailing adverse reactions observed in a minimum of 10% of patients who received treatment with this drug.[Ref]
Gastrointestinal
- Very common (10% or more): Diarrhea (20%), nausea (10%)
- Common (1% to 10%): Abdominal pain[Ref]
Genitourinary
- Common (1% to 10%): Urinary tract infections[Ref]
Hypersensitivity
- Very common (10% or more): Hypersensitivity reactions (11%)[Ref]
During clinical trials, hypersensitivity reactions were observed within a range of 1 day to 2 weeks following administration of this drug.
One patient discontinued treatment with this drug due to a hypersensitivity reaction.
Furthermore, local reactions at the site of administration were reported within 1 to 3 days after the most recent infusion of this drug.[Ref]
Local
- Common (1% to 10%): Administration site reactions[Ref]
Musculoskeletal
- Common (1% to 10%): Arthralgia[Ref]
Nervous system
- Very common (10% or more): Headache (44%)[Ref]
Cases of severe headache were reported in 5.3% of patients.
A patient required hospitalization due to a severe headache, while another patient discontinued treatment as a result of a severe headache accompanied by fever, photophobia, phonophobia, nausea, and vertigo.[Ref]
Other
- Very common (10% or more): Any infection (23%), pyrexia (17%)
- Common (1% to 10%): Herpes simplex[Ref]
Respiratory
- Very common (10% or more): COVID-19 infection (14%)
- Common (1% to 10%): Upper respiratory tract infection[Ref]
Three fatal cases of pneumonia were identified, with two cases attributed to COVID-19 infection and one case caused by an unknown pathogen.[Ref]
References
1. (2023) "Product Information. Rystiggo (rozanolixizumab)." UCB Pharma Inc
More about rozanolixizumab
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- During pregnancy
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Further information
Rozanolixizumab 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.