Drug · FAERS side-effect profile with label screen
Nusinersen side effects: what 7,633 FDA adverse event reports show
Drug class
Survival Motor Neuron-2-directed RNA Interaction, Antisense Oligonucleotide
FDA label (Established Pharmacologic Class)
Brand names
Spinraza
openFDA label
Who reports
7,633 reports · 50% serious · 790 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients ( 1 )
FDA label, Indications and Usage
What it is
Nusinersen is a modified antisense oligonucleotide, where the 2'-hydroxy groups of the ribofuranosyl rings are replaced with 2'-O-2-methoxyethyl groups and the phosphate linkages are replaced with phosphorothioate linkages.
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 40 strongest signals
Labeled adverse reaction 7Labeled (related wording) 4Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 2Outcome field, not a reaction 1Not in label — unassessed 22
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 123 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Procedural pain | 375 | 37.6 34.1–41.6ROR 39.5 · χ² 13,174 / p <1e-300 | 37.1 EB05 34.0 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.7 · 88% consumer | no trial data cached |
| Motor dysfunction | 84 | 22.9 18.5–28.4ROR 23.2 · χ² 1,726 / p <1e-300 | 22.6 EB05 18.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 | no trial data cached |
| Sars-cov-2 test positive | 75 | 15.5 12.3–19.4ROR 15.6 · χ² 995 / p 1e-218 | 15.3 EB05 12.6 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=9 | no trial data cached |
| Aspiration | 56 | 14.2 11.0–18.5ROR 14.3 · χ² 672 / p 2e-148 | 14.0 EB05 11.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.6 | no trial data cached |
| Atelectasis | 48 | 13.6 10.3–18.1ROR 13.7 · χ² 546 / p 4e-121 | 13.3 EB05 10.3 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.5 | no trial data cached |
| Respiratory disorder | 136 | 12.5 10.6–14.7ROR 12.7 · χ² 1,419 / p <1e-300 | 12.3 EB05 10.7 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.0 | no trial data cached |
| Respiratory tract infection | 117 | 12.4 10.3–14.8ROR 12.6 · χ² 1,210 / p 2e-265 | 12.2 EB05 10.5 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.8 | no trial data cached |
| Therapeutic response shortened | 133 | 11.5 9.7–13.6ROR 11.7 · χ² 1,260 / p 3e-276 | 11.3 EB05 9.8 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 74% consumer | no trial data cached |
| Post procedural complication | 62 | 8.9 6.9–11.3ROR 8.9 · χ² 423 / p 3e-94 | 8.5 EB05 6.8 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · 75% consumer | no trial data cached |
| Pneumothorax | 49 | 8.5 6.4–11.2ROR 8.5 · χ² 316 / p 7e-71 | 8.0 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Secretion discharge | 38 | 8.4 6.1–11.6ROR 8.5 · χ² 241 / p 9e-55 | 7.9 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 · 84% consumer | no trial data cached |
| Acute respiratory failure | 57 | 8.2 6.3–10.6ROR 8.2 · χ² 351 / p 1e-78 | 7.8 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Viral infection | 83 | 6.9 5.5–8.5ROR 6.9 · χ² 409 / p 3e-91 | 6.6 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 | no trial data cached |
| Joint dislocation | 26 | 6.8 4.6–10.0ROR 6.8 · χ² 122 / p 1e-28 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Respiratory distress | 67 | 6.7 5.2–8.5ROR 6.7 · χ² 316 / p 5e-71 | 6.4 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Pneumonia aspiration | 58 | 6.4 4.9–8.3ROR 6.4 · χ² 258 / p 2e-58 | 6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 | no trial data cached |
| Brain injury | 22 | 6.0 4.0–9.1ROR 6.0 · χ² 87 / p 6e-21 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Respiratory arrest | 59 | 5.8 4.5–7.5ROR 5.9 · χ² 231 / p 2e-52 | 5.6 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Hypotonia | 21 | 5.7 3.7–8.8ROR 5.8 · χ² 78 / p 7e-19 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Malnutrition | 23 | 5.7 3.8–8.5ROR 5.7 · χ² 84 / p 3e-20 | 5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 | no trial data cached |
| Gastroenteritis | 30 | 5.6 4.0–8.1ROR 5.7 · χ² 110 / p 5e-26 | 5.2 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Cardio-respiratory arrest | 85 | 5.5 4.5–6.8ROR 5.6 · χ² 312 / p 4e-70 | 5.4 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Femur fracture | 61 | 5.4 4.2–6.9ROR 5.4 · χ² 214 / p 1e-48 | 5.2 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Respiratory failure | 139 | 5.2 4.4–6.2ROR 5.3 · χ² 471 / p 8e-105 | 5.1 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Oxygen saturation decreased | 97 | 4.8 3.9–5.8ROR 4.8 · χ² 285 / p 3e-64 | 4.7 EB05 3.9 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 5.0 · 72% consumer | no trial data cached |
| Post procedural haemorrhage | 20 | 4.7 3.0–7.3ROR 4.7 · χ² 55 / p 8e-14 | 4.3 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Spinal disorder | 16 | 4.6 2.8–7.5ROR 4.6 · χ² 42 / p 5e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.3 | no trial data cached |
| Lower limb fracture | 29 | 4.2 2.9–6.0ROR 4.2 · χ² 67 / p 2e-16 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 93% consumer | no trial data cached |
| Proteinuria | 28 | 4.1 2.8–5.9ROR 4.1 · χ² 62 / p 2e-15 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Neuralgia | 35 | 4.0 2.8–5.5ROR 4.0 · χ² 74 / p 3e-18 | 3.8 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 1.7 · ♀ 73% (drug 51%) · 83% consumer | no trial data cached |
| Covid-19 pneumonia | 17 | 3.9 2.4–6.3ROR 3.9 · χ² 34 / p 3e-9 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 | no trial data cached |
| Sudden death | 15 | 3.8 2.3–6.4ROR 3.9 · χ² 29 / p 4e-8 | 3.5 EB05 2.3 · IC025 +0.9 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.4 | no trial data cached |
| Nephrolithiasis (kidney stones) | 62 | 3.7 2.9–4.8ROR 3.7 · χ² 121 / p 2e-28 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Influenza | 150 | 3.7 3.1–4.3ROR 3.7 · χ² 291 / p 2e-65 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Musculoskeletal disorder | 24 | 3.4 2.3–5.1ROR 3.4 · χ² 39 / p 2e-10 | 3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 79% consumer | no trial data cached |
| Muscular weakness | 141 | 3.4 2.9–4.0ROR 3.4 · χ² 238 / p 6e-54 | 3.4 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 · 72% consumer | no trial data cached |
| Ligament sprain | 12 | 3.3 1.9–5.9ROR 3.3 · χ² 17 / p 2e-5 | 3.0 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious n=3 | no trial data cached |
| Salivary hypersecretion | 12 | 3.3 1.9–5.8ROR 3.3 · χ² 17 / p 2e-5 | 3.0 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Pharyngitis streptococcal | 13 | 3.3 1.9–5.7ROR 3.3 · χ² 19 / p 8e-6 | 3.0 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | serious n=4 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 55 | 3.3 2.5–4.3ROR 3.3 · χ² 84 / p 2e-20 | 3.2 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 | 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 |
|---|---|---|---|---|---|---|
| Headache | 539 | 2.4 2.2–2.6ROR 2.5 · χ² 433 / p 2e-96 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 · 82% consumer | no trial data cached |
| Pyrexia (fever) | 401 | 3.2 2.9–3.5ROR 3.3 · χ² 605 / p 8e-134 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Procedural pain | 375 | 37.6 34.1–41.6ROR 39.5 · χ² 13,174 / p <1e-300 | 37.1 EB05 34.0 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.7 · 88% consumer | no trial data cached |
| Pneumonia (lung infection) | 367 | 3.1 2.8–3.4ROR 3.2 · χ² 532 / p 6e-118 | 3.1 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Death | 333 | 1.1 1.0–1.2ROR 1.1 · χ² 1 / p 0.149 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 1.2 | no trial data cached |
| Vomiting | 307 | 1.8 1.6–2.0ROR 1.8 · χ² 110 / p 6e-26 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Asthenia (weakness) | 291 | 2.1 1.9–2.4ROR 2.2 · χ² 174 / p 4e-40 | 2.1 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 0.8 · 80% consumer | no trial data cached |
| Back pain | 252 | 3.0 2.6–3.4ROR 3.0 · χ² 331 / p 3e-74 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.5 · 78% consumer | no trial data cached |
| Fall | 175 | 1.4 1.2–1.7ROR 1.5 · χ² 24 / p 6e-7 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.0 · 73% consumer | no trial data cached |
| Nasopharyngitis (common cold) | 163 | 2.4 2.1–2.8ROR 2.4 · χ² 135 / p 1e-31 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 · 82% consumer | no trial data cached |
| Influenza | 150 | 3.7 3.1–4.3ROR 3.7 · χ² 291 / p 2e-65 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Muscular weakness | 141 | 3.4 2.9–4.0ROR 3.4 · χ² 238 / p 6e-54 | 3.4 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 1.8 · 72% consumer | no trial data cached |
| Respiratory failure | 139 | 5.2 4.4–6.2ROR 5.3 · χ² 471 / p 8e-105 | 5.1 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Respiratory disorder | 136 | 12.5 10.6–14.7ROR 12.7 · χ² 1,419 / p <1e-300 | 12.3 EB05 10.7 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.0 | no trial data cached |
| Therapeutic response shortened | 133 | 11.5 9.7–13.6ROR 11.7 · χ² 1,260 / p 3e-276 | 11.3 EB05 9.8 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 74% consumer | 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.
- Motor dysfunction — n=84, PRR 22.9
- Pneumothorax — n=49, PRR 8.5
- Secretion discharge — n=38, PRR 8.4
- Acute respiratory failure — n=57, PRR 8.2
- Joint dislocation — n=26, PRR 6.8
- Respiratory distress — n=67, PRR 6.7
- Brain injury — n=22, PRR 6.0
- Respiratory arrest — n=59, PRR 5.8
- Hypotonia — n=21, PRR 5.7
- Gastroenteritis — n=30, PRR 5.6
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 Nusinersen?
In FDA FAERS, the most frequently co-reported reaction terms for Nusinersen are headache, pyrexia, procedural pain, pneumonia, vomiting, asthenia. 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 Nusinersen have an FDA boxed warning?
No. The FDA label retrieved for Nusinersen has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nusinersen 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 dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94, effective 20260331; matched on
openfda.generic_name.exact:"NUSINERSEN") - 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, fieldpatient.drug.openfda.generic_name.exact, 163 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.