Eptinezumab-Jjmr side effects: what 9,044 FDA adverse event reports show

Eptinezumab-Jjmr · Vyepti · 641 reaction terms · 19,634 drug–reaction co-reports · data 2026-09-14

Drug class

Calcitonin Gene-related Peptide Antagonist

FDA label (Established Pharmacologic Class)

Brand names

Vyepti

openFDA label

Who reports

9,044 reports · 25% serious · 63 with death outcome · 86% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VYEPTI is indicated for the preventive treatment of migraine in adults. VYEPTI is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults ( 1 )

FDA label, Indications and Usage

What it is

Eptinezumab-jjmr is a humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand. Eptinezumab-jjmr has an approximate molecular weight of 143 kD. Eptinezumab-jjmr is produced in Pichia pastoris yeast cells by recombinant DNA technology.

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 (related wording) 4Likely indication confounding 2Reporting / coding artifact 7Not in label — unassessed 27

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.
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.
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. 601 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
Therapeutic response delayed	120	104.2 86.9–125.0ROR 105.6 · χ² 11,633 / p <1e-300	98.2 EB05 84.3 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious n=19 · 93% consumer	no trial data cached
Hemiplegic migraine	14	102.6 60.1–175.2ROR 102.7 · χ² 1,252 / p 1e-274	86.9 EB05 55.0 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=11	no trial data cached
Drug effect less than expected	361	60.9 55.0–67.5ROR 63.4 · χ² 20,671 / p <1e-300	59.2 EB05 54.2 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	serious n=39 · 75% consumer	no trial data cached
Therapeutic response shortened	566	42.0 38.7–45.5ROR 44.7 · χ² 22,214 / p <1e-300	41.2 EB05 38.4 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious PRR 43.4 · 76% consumer	no trial data cached
Migraine	1,473	36.5 34.9–38.3ROR 43.5 · χ² 50,316 / p <1e-300	36.0 EB05 34.5 · IC025 +5.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 39.7 · 78% consumer	no trial data cached
Aura	27	34.1 23.3–49.9ROR 34.2 · χ² 823 / p 3e-181	32.9 EB05 23.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Tongue pruritus	12	33.4 18.9–59.1ROR 33.5 · χ² 341 / p 2e-76	31.5 EB05 19.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Infusion site bruising	27	29.8 20.4–43.5ROR 29.9 · χ² 714 / p 2e-157	28.9 EB05 20.8 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=3 · 85% consumer	no trial data cached
Infusion site rash	17	29.3 18.1–47.2ROR 29.3 · χ² 431 / p 5e-96	28.1 EB05 18.6 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious n=6	no trial data cached
Punctate keratitis	11	29.2 16.1–53.0ROR 29.3 · χ² 269 / p 9e-61	27.6 EB05 16.3 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Cluster headache	14	24.1 14.2–40.8ROR 24.1 · χ² 284 / p 5e-64	23.1 EB05 14.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Nasal pruritus	11	20.7 11.4–37.5ROR 20.7 · χ² 185 / p 2e-42	19.5 EB05 11.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Throat irritation	348	18.2 16.4–20.2ROR 18.9 · χ² 5,599 / p <1e-300	18.0 EB05 16.5 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.8	no trial data cached
Pharyngeal paraesthesia	11	16.4 9.1–29.8ROR 16.5 · χ² 143 / p 2e-33	15.1 EB05 7.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Infusion site extravasation	42	15.7 11.6–21.3ROR 15.8 · χ² 562 / p 2e-124	15.5 EB05 11.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Electric shock sensation	17	14.7 9.2–23.7ROR 14.8 · χ² 203 / p 2e-46	13.9 EB05 8.6 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Therapeutic product effect delayed	26	13.4 9.1–19.7ROR 13.5 · χ² 285 / p 3e-64	12.9 EB05 8.9 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial data cached
Urinary bladder haemorrhage	11	12.1 6.7–21.9ROR 12.1 · χ² 101 / p 5e-24	10.2 EB05 5.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Trigeminal neuralgia	20	11.6 7.5–17.9ROR 11.6 · χ² 182 / p 1e-41	10.6 EB05 6.8 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=16 · 75% consumer	no trial data cached
Brain fog	70	11.2 8.8–14.1ROR 11.2 · χ² 635 / p 2e-140	10.9 EB05 8.8 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Haematological infection	11	11.0 6.1–19.9ROR 11.0 · χ² 90 / p 1e-21	9.1 EB05 4.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Tension headache	19	10.3 6.6–16.1ROR 10.3 · χ² 150 / p 1e-34	9.2 EB05 5.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Oral pruritus	10	10.2 5.5–18.9ROR 10.2 · χ² 73 / p 6e-18	8.0 EB05 4.3 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Nasal congestion (stuffy nose)	247	9.8 8.7–11.1ROR 10.1 · χ² 1,945 / p <1e-300	9.7 EB05 8.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Infusion site pruritus	13	9.7 5.6–16.7ROR 9.7 · χ² 93 / p 3e-22	8.1 EB05 4.7 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious n=2	no trial data cached
White blood cell disorder	11	9.5 5.3–17.2ROR 9.5 · χ² 75 / p 2e-18	7.6 EB05 4.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Sneezing	90	9.4 7.6–11.5ROR 9.4 · χ² 662 / p 3e-146	9.1 EB05 7.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Infusion site pain	48	8.7 6.6–11.6ROR 8.8 · χ² 320 / p 6e-72	8.3 EB05 6.4 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious n=6	no trial data cached
Throat clearing	13	8.1 4.7–14.0ROR 8.1 · χ² 74 / p 4e-18	6.7 EB05 4.0 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Pharyngeal swelling	29	7.0 4.9–10.1ROR 7.1 · χ² 144 / p 2e-33	6.4 EB05 4.6 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Mouth swelling	17	6.9 4.3–11.1ROR 6.9 · χ² 79 / p 3e-19	5.9 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious n=14	no trial data cached
Hysterectomy	25	6.7 4.5–10.0ROR 6.7 · χ² 116 / p 2e-27	6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 16.4	no trial data cached
Shoulder operation	12	6.6 3.8–11.7ROR 6.6 · χ² 52 / p 3e-13	5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious n=12	no trial data cached
Incorrect drug administration rate	12	6.6 3.7–11.6ROR 6.6 · χ² 51 / p 4e-13	5.4 EB05 3.3 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious n=4	no trial data cached
Paraesthesia oral	38	6.1 4.5–8.4ROR 6.2 · χ² 158 / p 1e-36	5.7 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached
Facial pain	23	6.0 4.0–9.0ROR 6.0 · χ² 90 / p 1e-21	5.4 EB05 3.8 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious n=14 · 96% consumer	no trial data cached
Cataract operation	15	5.9 3.5–9.8ROR 5.9 · χ² 56 / p 4e-14	5.0 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious n=15	no trial data cached
Infusion site swelling	15	5.7 3.4–9.4ROR 5.7 · χ² 53 / p 2e-13	4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Feeling of despair	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	Not in label — unassessed	serious n=11	no trial data cached
Rash vesicular	11	5.3 2.9–9.6ROR 5.3 · χ² 34 / p 3e-9	4.4 EB05 2.7 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious n=11	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
Drug ineffective (drug did not work)	2,046	3.6 3.5–3.7ROR 4.4 · χ² 4,102 / p <1e-300	3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 2.1 · 77% consumer	no trial data cached
Migraine	1,473	36.5 34.9–38.3ROR 43.5 · χ² 50,316 / p <1e-300	36.0 EB05 34.5 · IC025 +5.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 39.7 · 78% consumer	no trial data cached
Headache	953	3.5 3.3–3.8ROR 3.8 · χ² 1,778 / p <1e-300	3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 3.1 · 74% consumer	no trial data cached
Therapeutic response shortened	566	42.0 38.7–45.5ROR 44.7 · χ² 22,214 / p <1e-300	41.2 EB05 38.4 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious PRR 43.4 · 76% consumer	no trial data cached
Nausea	543	1.6 1.5–1.7ROR 1.6 · χ² 125 / p 3e-29	1.6 EB05 1.5 · IC025 +0.5	Not in label — unassessed	serious PRR 1.7	no trial data cached
Fatigue (tiredness)	490	1.5 1.3–1.6ROR 1.5 · χ² 74 / p 4e-18	1.5 EB05 1.4 · IC025 +0.4	Labeled adverse reaction exact term	serious PRR 1.6	no trial data cached
Drug effect less than expected	361	60.9 55.0–67.5ROR 63.4 · χ² 20,671 / p <1e-300	59.2 EB05 54.2 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	serious n=39 · 75% consumer	no trial data cached
Dizziness	350	1.6 1.5–1.8ROR 1.7 · χ² 87 / p 7e-21	1.6 EB05 1.5 · IC025 +0.5	Not in label — unassessed	serious PRR 2.2	no trial data cached
Throat irritation	348	18.2 16.4–20.2ROR 18.9 · χ² 5,599 / p <1e-300	18.0 EB05 16.5 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.8	no trial data cached
Pruritus (itching)	308	1.9 1.7–2.1ROR 1.9 · χ² 130 / p 2e-30	1.9 EB05 1.7 · IC025 +0.7	Labeled adverse reaction exact term	serious PRR 1.9	no trial data cached
Nasal congestion (stuffy nose)	247	9.8 8.7–11.1ROR 10.1 · χ² 1,945 / p <1e-300	9.7 EB05 8.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Hypersensitivity (allergic reaction)	207	2.6 2.3–3.0ROR 2.6 · χ² 202 / p 4e-46	2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.5	no trial data cached
Vomiting	202	1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.494	1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 0.9	no trial data cached
Dyspnoea (shortness of breath)	200	0.8 0.7–0.9ROR 0.8 · χ² 8 / p 0.002	0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 1.3	no trial data cached
Malaise (feeling unwell)	182	1.0 0.8–1.1ROR 1.0 · χ² 0 / p 0.300	1.0 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 1.0 · 73% 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.

Aura — n=27, PRR 34.1
Infusion site bruising — n=27, PRR 29.8
Throat irritation — n=348, PRR 18.2
Infusion site extravasation — n=42, PRR 15.7
Trigeminal neuralgia — n=20, PRR 11.6
Brain fog — n=70, PRR 11.2
Nasal congestion — n=247, PRR 9.8
Sneezing — n=90, PRR 9.4
Pharyngeal swelling — n=29, PRR 7.0
Hysterectomy — n=25, PRR 6.7

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 Eptinezumab-Jjmr?

In FDA FAERS, the most frequently co-reported reaction terms for Eptinezumab-Jjmr are migraine, headache, nausea, fatigue, dizziness, throat irritation. 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 Eptinezumab-Jjmr have an FDA boxed warning?

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

Do FAERS signals prove that Eptinezumab-Jjmr 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 79065861-6aa5-4d1f-829f-3a6471286b36, effective 20260605; matched on openfda.generic_name.exact:"EPTINEZUMAB-JJMR")
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, 641 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.