Rystiggo Side Effects

Generic name: rozanolixizumab

Medically reviewed by Drugs.com. Last updated on Apr 29, 2025.

Note: This document provides detailed information about Rystiggo.

Applies to rozanolixizumab: subcutaneous solution Side Effects associated with rozanolixizumab. Some dosage forms listed on this page may not apply specifically to the brand name Rystiggo.

Applies to rozanolixizumab: subcutaneous solution.

Precautions

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

This medicine may increase your risk of infection. Check with your doctor right away if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Check with your doctor if you have fever, headache, nausea, stiff neck or back, or vomiting. These may be symptoms of aseptic meningitis (swelling of the brain).

This medicine may cause serious allergic reaction, including angioedema and rash, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs.

While you are being treated with rozanolixizumab-noli injection, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Rozanolixizumab-noli may lower your body's resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Rystiggo

Along with its needed effects, rozanolixizumab (the active ingredient contained in Rystiggo) 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:

Other side effects of Rystiggo

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:

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]

See also:

Frequently asked questions

• What is the mechanism of action for Rystiggo?
• How long does it take Rystiggo to work?

Further information

Rystiggo 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