Rozanolixizumab side effects: what 1,025 FDA adverse event reports show

Rozanolixizumab · Rystiggo · 16 reaction terms · 317 drug–reaction co-reports · data 2026-09-14

Drug class

Neonatal Fc Receptor Blocker

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Rystiggo

openFDA label

Who reports

1,025 reports · 70% serious · 18 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

RYSTIGGO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. RYSTIGGO (rozanolixizumab-noli) is a neonatal .

FDA label, Indications and Usage

What it is

Rozanolixizumab-noli, a neonatal Fc receptor blocker, is a recombinant, humanized IgG4P monoclonal antibody, expressed in a genetically engineered Chinese hamster ovary DG44 cell line. Rozanolixizumab-noli has an approximate molecular weight of 148 kDa.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 13 strongest signals

Labeled (related wording) 1Reporting / coding artifact 7Not in label — unassessed 5

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 3 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Eyelid ptosis	23	46.3 30.9–69.4ROR 47.4 · χ² 973 / p 6e-214	44.6 EB05 31.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=17	no trial data cached
Therapeutic response shortened	54	34.7 26.8–45.0ROR 36.6 · χ² 1,735 / p <1e-300	34.3 EB05 27.3 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 77.2 · 78% consumer	no trial data cached
Insurance issue	22	30.3 20.0–45.8ROR 31.0 · χ² 594 / p 2e-131	29.6 EB05 20.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 51.2 · 91% consumer	no trial data cached
Diplopia (double vision)	31	24.4 17.3–34.5ROR 25.1 · χ² 673 / p 1e-148	24.1 EB05 17.8 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 18.5 · 71% consumer	no trial data cached
Therapy interrupted	42	12.4 9.3–16.7ROR 12.9 · χ² 432 / p 3e-96	12.1 EB05 9.2 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 18.3 · 79% consumer	no trial data cached
Dysarthria (slurred speech)	19	10.3 6.6–16.1ROR 10.5 · χ² 151 / p 5e-35	9.2 EB05 5.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Spinal operation	6	10.1 4.6–22.5ROR 10.2 · χ² 41 / p 9e-11	6.9 EB05 3.1 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 9.0	no trial data cached
Therapeutic response decreased	22	7.5 4.9–11.3ROR 7.6 · χ² 117 / p 1e-27	6.6 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5	no trial data cached
Hospitalisation	54	7.2 5.6–9.4ROR 7.6 · χ² 286 / p 1e-64	6.9 EB05 5.5 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 6.1	no trial data cached
Product availability issue	7	6.4 3.1–13.4ROR 6.4 · χ² 27 / p 1e-7	4.7 EB05 2.5 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 7.7	no trial data cached
Injection site rash	5	3.4 1.4–8.1ROR 3.4 · χ² 6 / p 0.007	2.8 EB05 1.3 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Labeled (related wording) related wording	serious n=5	no trial data cached
Device issue	13	3.0 1.8–5.2ROR 3.1 · χ² 16 / p 3e-5	2.8 EB05 1.8 · IC025 +0.6	Reporting / coding artifact	serious PRR 7.3	no trial data cached
Injection site bruising	10	2.6 1.4–4.8ROR 2.6 · χ² 8 / p 0.002	2.4 EB05 1.4 · IC025 +0.2	Not in label — unassessed	serious PRR 10.3	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hospitalisation	54	7.2 5.6–9.4ROR 7.6 · χ² 286 / p 1e-64	6.9 EB05 5.5 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 6.1	no trial data cached
Therapeutic response shortened	54	34.7 26.8–45.0ROR 36.6 · χ² 1,735 / p <1e-300	34.3 EB05 27.3 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 77.2 · 78% consumer	no trial data cached
Therapy interrupted	42	12.4 9.3–16.7ROR 12.9 · χ² 432 / p 3e-96	12.1 EB05 9.2 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 18.3 · 79% consumer	no trial data cached
Diplopia (double vision)	31	24.4 17.3–34.5ROR 25.1 · χ² 673 / p 1e-148	24.1 EB05 17.8 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 18.5 · 71% consumer	no trial data cached
Eyelid ptosis	23	46.3 30.9–69.4ROR 47.4 · χ² 973 / p 6e-214	44.6 EB05 31.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=17	no trial data cached
Therapeutic response decreased	22	7.5 4.9–11.3ROR 7.6 · χ² 117 / p 1e-27	6.6 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5	no trial data cached
Insurance issue	22	30.3 20.0–45.8ROR 31.0 · χ² 594 / p 2e-131	29.6 EB05 20.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 51.2 · 91% consumer	no trial data cached
Dysarthria (slurred speech)	19	10.3 6.6–16.1ROR 10.5 · χ² 151 / p 5e-35	9.2 EB05 5.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Device issue	13	3.0 1.8–5.2ROR 3.1 · χ² 16 / p 3e-5	2.8 EB05 1.8 · IC025 +0.6	Reporting / coding artifact	serious PRR 7.3	no trial data cached
Injection site bruising	10	2.6 1.4–4.8ROR 2.6 · χ² 8 / p 0.002	2.4 EB05 1.4 · IC025 +0.2	Not in label — unassessed	serious PRR 10.3	no trial data cached
Product availability issue	7	6.4 3.1–13.4ROR 6.4 · χ² 27 / p 1e-7	4.7 EB05 2.5 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 7.7	no trial data cached
Spinal operation	6	10.1 4.6–22.5ROR 10.2 · χ² 41 / p 9e-11	6.9 EB05 3.1 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 9.0	no trial data cached
Injection site rash	5	3.4 1.4–8.1ROR 3.4 · χ² 6 / p 0.007	2.8 EB05 1.3 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Labeled (related wording) related wording	serious n=5	no trial data cached
Device defective	3	3.8 1.2–11.7ROR 3.8 · χ² 4 / p 0.027	2.7 EB05 1.1 · IC025 -0.6 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious n=1	no trial data cached
Injection site discomfort	3	5.9 1.9–18.4ROR 6.0 · χ² 8 / p 0.002	3.5 EB05 1.4 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious n=3	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Eyelid ptosis — n=23, PRR 46.3
Insurance issue — n=22, PRR 30.3
Diplopia — n=31, PRR 24.4

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Rozanolixizumab?

In FDA FAERS, the most frequently co-reported reaction terms for Rozanolixizumab are diplopia, eyelid ptosis, insurance issue, dysarthria, injection site bruising, injection site rash. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Rozanolixizumab have an FDA boxed warning?

No. The FDA label retrieved for Rozanolixizumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Rozanolixizumab causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 3c0eb8c2-c042-4954-b451-3baa77f5e6d1, effective 20260120; matched on openfda.generic_name.exact:"ROZANOLIXIZUMAB")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 16 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.