What the label lists and what reports show
Rozanolixizumab side effects
Rozanolixizumab's FDA label: “The most common adverse reactions (≥10%) in patients with gMG are headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.” FAERS holds 1,026 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (159 reports).
- No generic listed
Check it at the source: the rozanolixizumab FDA label on DailyMed (effective January 20, 2026); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥10%) in patients with gMG are headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.
Table 2: Adverse Reactions in at least 5% of Patients Treated with RYSTIGGO and More Frequently than in Patients who Received Placebo in Study 1 (Safety Population)
| Adverse Reaction | RYSTIGGO (N = 133) % | Placebo (N = 67) % |
|---|---|---|
| Headache | 44 | 19 |
| Any infection | 23 | 19 |
| Upper respiratory tract infection | 8 | 6 |
| Diarrhea | 20 | 13 |
| Pyrexia | 17 | 2 |
| Hypersensitivity reactions | 11 | 5 |
| Nausea | 10 | 8 |
| Administration site reactions | 8 | 3 |
| Abdominal pain | 8 | 6 |
| Arthralgia | 7 | 3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Infections [see Warnings and Precautions (5.1) ] Aseptic Meningitis [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥10%) in patients with gMG are headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, the safety of RYSTIGGO has been evaluated in 196 patients who received at least one dose of RYSTIGGO, including 88 patients exposed to at least 5 treatment cycles and 9 patients exposed to at least 10 treatment cycles. In a placebo-controlled study (Study 1) in patients with gMG, 133 patients received RYSTIGGO [see Clinical Studies (14) ]. Of these 133 patients, approximately 56% were female, 68% were White, 12% were Asian, and 6% were of Hispanic or Latino ethnicity. …
Source: FDA drug label, UCB, Inc., effective January 20, 2026 (SPL set 3c0eb8c2-c042-4954-b451-3baa77f5e6d1), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,026 reports list rozanolixizumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 18 are coded as a death and 339 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Rozanolixizumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions