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Rozanolixizumab Side Effects

The most commonly reported side effects of rozanolixizumab include myasthenia gravis, headache, and diarrhoea, based on 793 FDA adverse event reports from 2013 to 2025. 16.6% of reports found the drug to be ineffective.

Rozanolixizumab side effects

Percentages show how often each reaction appears relative to total reports for rozanolixizumab.

1
Myasthenia Gravis31.7%251
2
Headache16.9%134
3
Drug Ineffective16.6%132
4
Diarrhoea10.3%82
5
Fatigue8.8%70
6
Nausea8.4%67
7
Asthenia7.4%59
8
Dyspnoea6.9%55
9
Pyrexia5.5%44
10
Vomiting5.3%42
11
Therapeutic Response Shortened5.0%40
12
Dysphagia4.4%35
13
Dizziness4.4%35
14
Therapy Interrupted4.3%34
15
Myasthenia Gravis Crisis4.3%34

These are voluntary reports and do not establish that rozanolixizumab caused these reactions.

Report severity

71.0%Serious563 reports
31.0%Hospitalizations246 reports
1.9%Fatal15 reports

Seriousness is determined by the reporter, not by OpenClaim.

Rozanolixizumab drug interactions

Other drugs that appear in adverse event reports alongside rozanolixizumab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Zilucoplan-sodium2.8%22
2
Prednisone1.8%14
3
Ravulizumab-cwvz1.0%8
4
Tacrolimus0.9%7
5
Eculizumab0.8%6
6
Efgartigimod0.5%4
7
Prednisolone0.5%4
8
Tirzepatide0.5%4
9
Mycophenolate0.4%3
10
Azathioprine0.4%3
11
Rituximab0.4%3
12
Pyridostigmine-bromide0.4%3
13
Acetaminophen0.4%3
14
Ibuprofen0.4%3
15
Cetirizine-hydrochloride0.3%2

Taken alongside

1
Pyridostigmine-bromide15.0%119
2
Prednisone13.0%103
3
Epinephrine6.7%53
4
Acetaminophen3.9%31
5
Prednisolone3.4%27
6
Mycophenolate3.3%26
7
Ergocalciferol2.8%22
8
Levothyroxine-sodium2.3%18
9
Atorvastatin-calcium2.1%17
10
Metformin2.1%17
11
Aspirin2.0%16
12
Insulin2.0%16
13
Azathioprine1.9%15
14
Ondansetron1.8%14
15
Tacrolimus1.8%14

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports rozanolixizumab side effects

39.6% of rozanolixizumab adverse event reports involve female patients and 29.1% involve male patients. The largest age group is adult at 53%. These figures reflect who reports side effects, not underlying risk.

Sex

Female39.6%
Male29.1%
Unknown31.3%

Age group

< 20.0%
2–110.3%
12–170.3%
18–6453.1%
65+46.4%

What is rozanolixizumab used for

Conditions and purposes for which patients were taking rozanolixizumab when the adverse event was reported.

Aortic ArteriosclerosisAsthmaChronic Inflammatory Demyelinating PolyradiculoneuropathyEncephalitis AutoimmuneEssential HypertensionHeadacheImmune ThrombocytopeniaMuscular WeaknessMyasthenia GravisMyasthenic SyndromeMyelin Oligodendrocyte Glycoprotein Antibody-associated DiseaseNeonatal Lupus ErythematosusOff Label UseOsteoporosisProduct Used For Unknown Indication

Showing 15 of 18 indications

Rozanolixizumab brand names and reporting trend

Rozanolixizumab is sold under the brand name Rystiggo.

Brand names

Rystiggo554

Quarterly reports (20132025)

201320242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking rozanolixizumab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.