Vutrisiran side effects: what 2,524 FDA adverse event reports show

Vutrisiran · Amvuttra · 35 reaction terms · 1,940 drug–reaction co-reports · data 2026-09-14

Drug class

Transthyretin-directed small interfering rna

FDA label, Indications wording

Brand names

Amvuttra

openFDA label

Who reports

2,524 reports · 84% serious · 635 with death outcome · 38% female

openFDA FAERS counts, all years, deduplication not applied

Used for

AMVUTTRA is a transthyretin-directed small interfering RNA indicated for the treatment of: the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults ( 1.1 ) the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloi.

FDA label, Indications and Usage

What it is

AMVUTTRA contains vutrisiran, a chemically modified double-stranded small interfering ribonucleic acid (siRNA) that targets mutant and wild-type transthyretin (TTR) messenger RNA (mRNA) and is.

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 27 strongest signals

Labeled (related wording) 1Reporting / coding artifact 10Outcome field, not a reaction 1Not in label — unassessed 15

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.
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. 8 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
Intentional dose omission	201	61.3 53.7–70.1ROR 66.5 · χ² 11,793 / p <1e-300	60.5 EB05 53.8 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious PRR 84.5	no trial data cached
Hospitalisation	311	16.9 15.3–18.8ROR 19.2 · χ² 4,672 / p <1e-300	16.9 EB05 15.4 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 11.9 · 71% consumer	no trial data cached
Spinal operation	20	13.7 8.9–21.2ROR 13.8 · χ² 223 / p 1e-50	13.0 EB05 8.4 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 10.2 · 80% consumer	no trial data cached
Therapy interrupted	85	10.2 8.3–12.6ROR 10.5 · χ² 699 / p 3e-154	10.0 EB05 8.3 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 14.5	no trial data cached
Carpal tunnel syndrome	17	10.0 6.2–16.1ROR 10.1 · χ² 129 / p 3e-30	8.8 EB05 5.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.5	no trial data cached
Therapeutic response shortened	32	8.3 5.9–11.8ROR 8.4 · χ² 199 / p 1e-45	7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 9.4	no trial data cached
Cardiac failure (heart failure)	78	8.0 6.5–10.0ROR 8.3 · χ² 476 / p 9e-106	7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Ill-defined disorder	52	7.1 5.4–9.3ROR 7.2 · χ² 266 / p 3e-60	6.7 EB05 5.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.9 · 79% consumer	no trial data cached
Drug effect less than expected	12	7.1 4.0–12.4ROR 7.1 · χ² 56 / p 3e-14	5.7 EB05 3.5 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious n=6	no trial data cached
Glaucoma	15	6.5 3.9–10.7ROR 6.5 · χ² 64 / p 7e-16	5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Knee arthroplasty	16	6.4 3.9–10.4ROR 6.4 · χ² 67 / p 1e-16	5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 3.7	no trial data cached
Unevaluable event	54	5.9 4.5–7.7ROR 6.0 · χ² 216 / p 3e-49	5.6 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 5.8 · 70% consumer	no trial data cached
Atrial fibrillation	63	5.4 4.2–6.8ROR 5.5 · χ² 219 / p 6e-50	5.2 EB05 4.2 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.7 · 76% consumer	no trial data cached
Gout	11	5.1 2.8–9.2ROR 5.1 · χ² 32 / p 8e-9	4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.3	no trial data cached
Dementia	17	5.1 3.1–8.1ROR 5.1 · χ² 51 / p 4e-13	4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 3.7	no trial data cached
Death	501	4.8 4.5–5.2ROR 5.8 · χ² 1,577 / p <1e-300	4.8 EB05 4.5 · IC025 +2.1 3/3 methods agree	Outcome field, not a reaction	serious PRR 3.3	no trial data cached
Hip fracture	18	4.6 2.9–7.4ROR 4.7 · χ² 48 / p 2e-12	4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 3.2	no trial data cached
Neuropathy peripheral (nerve damage in hands/feet)	50	4.4 3.3–5.8ROR 4.5 · χ² 128 / p 7e-30	4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.4 · 72% consumer	no trial data cached
Limb discomfort	15	4.0 2.4–6.7ROR 4.0 · χ² 31 / p 1e-8	3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.4	no trial data cached
Surgery	28	4.0 2.8–5.8ROR 4.0 · χ² 60 / p 4e-15	3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 3.0 · 89% consumer	no trial data cached
Pericardial effusion	11	4.0 2.2–7.1ROR 4.0 · χ² 21 / p 2e-6	3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 2.5	no trial data cached
Product dose omission issue	133	3.9 3.3–4.6ROR 4.0 · χ² 284 / p 5e-64	3.8 EB05 3.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.3	no trial data cached
Cardiac disorder	42	3.7 2.7–5.0ROR 3.8 · χ² 81 / p 1e-19	3.6 EB05 2.8 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 2.5 · 76% consumer	no trial data cached
Fluid retention	21	3.4 2.2–5.2ROR 3.4 · χ² 34 / p 3e-9	3.2 EB05 2.2 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.0 · 86% consumer	no trial data cached
Therapy cessation	21	3.4 2.2–5.2ROR 3.4 · χ² 33 / p 4e-9	3.2 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 4.7	no trial data cached
Femur fracture	12	3.2 1.8–5.6ROR 3.2 · χ² 16 / p 3e-5	2.9 EB05 1.8 · IC025 +0.6	Not in label — unassessed	serious PRR 2.2	no trial data cached
Cerebrovascular accident (stroke)	48	2.3 1.8–3.1ROR 2.4 · χ² 36 / p 1e-9	2.3 EB05 1.8 · IC025 +0.7	Not in label — unassessed	serious PRR 1.6	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
Death	501	4.8 4.5–5.2ROR 5.8 · χ² 1,577 / p <1e-300	4.8 EB05 4.5 · IC025 +2.1 3/3 methods agree	Outcome field, not a reaction	serious PRR 3.3	no trial data cached
Hospitalisation	311	16.9 15.3–18.8ROR 19.2 · χ² 4,672 / p <1e-300	16.9 EB05 15.4 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 11.9 · 71% consumer	no trial data cached
Intentional dose omission	201	61.3 53.7–70.1ROR 66.5 · χ² 11,793 / p <1e-300	60.5 EB05 53.8 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious PRR 84.5	no trial data cached
Product dose omission issue	133	3.9 3.3–4.6ROR 4.0 · χ² 284 / p 5e-64	3.8 EB05 3.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.3	no trial data cached
Therapy interrupted	85	10.2 8.3–12.6ROR 10.5 · χ² 699 / p 3e-154	10.0 EB05 8.3 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 14.5	no trial data cached
Cardiac failure (heart failure)	78	8.0 6.5–10.0ROR 8.3 · χ² 476 / p 9e-106	7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Atrial fibrillation	63	5.4 4.2–6.8ROR 5.5 · χ² 219 / p 6e-50	5.2 EB05 4.2 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.7 · 76% consumer	no trial data cached
Unevaluable event	54	5.9 4.5–7.7ROR 6.0 · χ² 216 / p 3e-49	5.6 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 5.8 · 70% consumer	no trial data cached
Ill-defined disorder	52	7.1 5.4–9.3ROR 7.2 · χ² 266 / p 3e-60	6.7 EB05 5.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.9 · 79% consumer	no trial data cached
Neuropathy peripheral (nerve damage in hands/feet)	50	4.4 3.3–5.8ROR 4.5 · χ² 128 / p 7e-30	4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.4 · 72% consumer	no trial data cached
Cerebrovascular accident (stroke)	48	2.3 1.8–3.1ROR 2.4 · χ² 36 / p 1e-9	2.3 EB05 1.8 · IC025 +0.7	Not in label — unassessed	serious PRR 1.6	no trial data cached
Cardiac disorder	42	3.7 2.7–5.0ROR 3.8 · χ² 81 / p 1e-19	3.6 EB05 2.8 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 2.5 · 76% consumer	no trial data cached
Therapeutic response shortened	32	8.3 5.9–11.8ROR 8.4 · χ² 199 / p 1e-45	7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 9.4	no trial data cached
Surgery	28	4.0 2.8–5.8ROR 4.0 · χ² 60 / p 4e-15	3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 3.0 · 89% consumer	no trial data cached
Therapy cessation	21	3.4 2.2–5.2ROR 3.4 · χ² 33 / p 4e-9	3.2 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 4.7	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.

Cardiac failure — n=78, PRR 8.0
Ill-defined disorder — n=52, PRR 7.1
Atrial fibrillation — n=63, PRR 5.4
Cardiac disorder — n=42, PRR 3.7
Fluid retention — n=21, PRR 3.4
Cerebrovascular accident — n=48, PRR 2.3

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 Vutrisiran?

In FDA FAERS, the most frequently co-reported reaction terms for Vutrisiran are cardiac failure, atrial fibrillation, ill-defined disorder, neuropathy peripheral, cerebrovascular accident, cardiac disorder. 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 Vutrisiran have an FDA boxed warning?

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

Do FAERS signals prove that Vutrisiran 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 8db0facb-81b6-4006-9239-27dc6409c5d3, effective 20251106; matched on openfda.generic_name.exact:"VUTRISIRAN")
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, 35 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.