Satralizumab side effects: what 1,681 FDA adverse event reports show

Satralizumab · Enspryng · 38 reaction terms · 679 drug–reaction co-reports · data 2026-09-14

Drug class

Interleukin-6 (il-6) receptor antagonist

FDA label, Indications wording

Brand names

Enspryng

openFDA label

Who reports

1,681 reports · 78% serious · 99 with death outcome · 87% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. ( 1 )

FDA label, Indications and Usage

What it is

Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively.

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 18 strongest signals

Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 14

What the badges mean

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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 20 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
Syringe issue	18	12.8 8.1–20.3ROR 12.9 · χ² 184 / p 3e-42	11.9 EB05 7.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Lymphocyte count decreased	17	12.0 7.5–19.2ROR 12.1 · χ² 160 / p 5e-37	10.9 EB05 6.7 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 10.9	no trial data cached
Neuralgia	22	11.3 7.5–17.1ROR 11.4 · χ² 197 / p 6e-45	10.5 EB05 6.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	no trial data cached
Urinary tract infection (bladder infection)	136	10.0 8.5–11.7ROR 10.8 · χ² 1,096 / p 1e-240	9.8 EB05 8.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Fracture	15	9.9 6.0–16.3ROR 9.9 · χ² 111 / p 3e-26	8.5 EB05 5.1 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.0	no trial data cached
Paralysis	11	9.5 5.3–17.2ROR 9.6 · χ² 76 / p 2e-18	7.7 EB05 4.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.3	no trial data cached
Blindness	27	8.3 5.7–12.0ROR 8.4 · χ² 165 / p 4e-38	7.5 EB05 5.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Hepatic steatosis	12	8.0 4.6–14.1ROR 8.1 · χ² 67 / p 1e-16	6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 2.8	no trial data cached
Hepatic function abnormal	21	7.1 4.6–10.8ROR 7.1 · χ² 103 / p 1e-24	6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.1 · 90% clinician	no trial data cached
Osteonecrosis (bone death)	16	6.0 3.7–9.8ROR 6.1 · χ² 62 / p 2e-15	5.2 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.5	no trial data cached
Product complaint	11	5.5 3.0–9.9ROR 5.5 · χ² 36 / p 1e-9	4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Herpes zoster (shingles)	25	5.4 3.7–8.0ROR 5.5 · χ² 86 / p 1e-20	4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.9	no trial data cached
No adverse event	70	4.9 3.9–6.2ROR 5.1 · χ² 216 / p 3e-49	4.8 EB05 3.9 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0	no trial data cached
Covid-19	69	4.9 3.9–6.1ROR 5.0 · χ² 209 / p 1e-47	4.7 EB05 3.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.2	no trial data cached
Ill-defined disorder	23	4.7 3.1–7.1ROR 4.8 · χ² 64 / p 7e-16	4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.4	no trial data cached
Visual acuity reduced	12	4.5 2.5–7.8ROR 4.5 · χ² 29 / p 4e-8	3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.7	no trial data cached
Systemic lupus erythematosus	12	4.2 2.4–7.4ROR 4.2 · χ² 26 / p 1e-7	3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 3.2	no trial data cached
Accidental exposure to product	20	2.5 1.6–3.9ROR 2.5 · χ² 16 / p 2e-5	2.4 EB05 1.7 · IC025 +0.5	Reporting / coding artifact	serious PRR 5.2 · 75% consumer	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
Urinary tract infection (bladder infection)	136	10.0 8.5–11.7ROR 10.8 · χ² 1,096 / p 1e-240	9.8 EB05 8.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
No adverse event	70	4.9 3.9–6.2ROR 5.1 · χ² 216 / p 3e-49	4.8 EB05 3.9 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0	no trial data cached
Covid-19	69	4.9 3.9–6.1ROR 5.0 · χ² 209 / p 1e-47	4.7 EB05 3.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.2	no trial data cached
Blindness	27	8.3 5.7–12.0ROR 8.4 · χ² 165 / p 4e-38	7.5 EB05 5.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Herpes zoster (shingles)	25	5.4 3.7–8.0ROR 5.5 · χ² 86 / p 1e-20	4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.9	no trial data cached
Ill-defined disorder	23	4.7 3.1–7.1ROR 4.8 · χ² 64 / p 7e-16	4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.4	no trial data cached
Neuralgia	22	11.3 7.5–17.1ROR 11.4 · χ² 197 / p 6e-45	10.5 EB05 6.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	no trial data cached
Hepatic function abnormal	21	7.1 4.6–10.8ROR 7.1 · χ² 103 / p 1e-24	6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.1 · 90% clinician	no trial data cached
Accidental exposure to product	20	2.5 1.6–3.9ROR 2.5 · χ² 16 / p 2e-5	2.4 EB05 1.7 · IC025 +0.5	Reporting / coding artifact	serious PRR 5.2 · 75% consumer	no trial data cached
Syringe issue	18	12.8 8.1–20.3ROR 12.9 · χ² 184 / p 3e-42	11.9 EB05 7.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Lymphocyte count decreased	17	12.0 7.5–19.2ROR 12.1 · χ² 160 / p 5e-37	10.9 EB05 6.7 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 10.9	no trial data cached
Osteonecrosis (bone death)	16	6.0 3.7–9.8ROR 6.1 · χ² 62 / p 2e-15	5.2 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.5	no trial data cached
Fracture	15	9.9 6.0–16.3ROR 9.9 · χ² 111 / p 3e-26	8.5 EB05 5.1 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.0	no trial data cached
Breast cancer	14	1.9 1.1–3.1ROR 1.9 · χ² 5 / p 0.015	1.8 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 1.3	no trial data cached
Device issue	14	2.0 1.2–3.4ROR 2.0 · χ² 6 / p 0.007	1.9 EB05 1.2 · IC025 +0.0	Reporting / coding artifact	serious PRR 2.0	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.

Neuralgia — n=22, PRR 11.3
Urinary tract infection — n=136, PRR 10.0
Blindness — n=27, PRR 8.3
Hepatic function abnormal — n=21, PRR 7.1
Herpes zoster — n=25, PRR 5.4
Covid-19 — n=69, PRR 4.9
Ill-defined disorder — n=23, PRR 4.7

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 Satralizumab?

In FDA FAERS, the most frequently co-reported reaction terms for Satralizumab are urinary tract infection, covid-19, blindness, herpes zoster, ill-defined disorder, neuralgia. 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 Satralizumab have an FDA boxed warning?

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

Do FAERS signals prove that Satralizumab 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 64c156a4-9bad-4d45-a294-0733c141f47b, effective 20260622; matched on openfda.generic_name.exact:"SATRALIZUMAB")
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, 38 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.