Prabotulinum Toxin Type A side effects: what 3,775 FDA adverse event reports show

Prabotulinum Toxin Type A · Jeuveau · 25 reaction terms · 4,757 drug–reaction co-reports · data 2026-09-14

Drug class

Acetylcholine Release Inhibitor, Neuromuscular Blocker

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Jeuveau

openFDA label

Who reports

3,775 reports · 2% serious · 1 with death outcome · 91% female

openFDA FAERS counts, all years, deduplication not applied

Used for

JEUVEAU is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. JEUVEAU is an acetylcholine release inhibitor and a neuromuscular b.

FDA label, Indications and Usage

What it is

PrabotulinumtoxinA-xvfs is an acetylcholine release inhibitor and a neuromuscular blocking agent. PrabotulinumtoxinA-xvfs is supplied as a sterile, vacuum-dried powder in a single-dose vial intended for intramuscular use after reconstitution.

FDA label, Description section

Boxed warning

DISTANT SPREAD OF TOXIN EFFECT The effects of all botulinum toxin products, including JEUVEAU, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death.

FDA 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 17 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 1Labeled (related wording) 8Reporting / coding artifact 6Not in label — unassessed 1

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
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.
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. 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
Drug effect less than expected	469	191.2 175.4–208.4ROR 218.2 · χ² 85,609 / p <1e-300	183.4 EB05 169.9 · IC025 +7.1 3/3 methods agree	Reporting / coding artifact	92% clinician	no trial data cached
Therapeutic product effect decreased	715	91.0 85.1–97.2ROR 112.0 · χ² 62,614 / p <1e-300	89.3 EB05 83.9 · IC025 +6.3 3/3 methods agree	Reporting / coding artifact	94% clinician	no trial data cached
Eyelid ptosis	73	40.1 32.0–50.4ROR 40.9 · χ² 2,729 / p <1e-300	39.5 EB05 32.5 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious n=4	no trial data cached
Off label use (used outside approved label)	1,314	8.4 8.1–8.8ROR 12.4 · χ² 8,944 / p <1e-300	8.4 EB05 8.0 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 7.5	no trial data cached
Injection site swelling	99	7.3 6.0–8.8ROR 7.4 · χ² 530 / p 1e-117	7.1 EB05 6.0 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 69.9 · 91% clinician	no trial data cached
Drug ineffective (drug did not work)	1,589	6.7 6.5–7.0ROR 10.9 · χ² 8,223 / p <1e-300	6.7 EB05 6.4 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 2.2 · 91% clinician	no trial data cached
Injection site irritation	12	5.3 3.0–9.3ROR 5.3 · χ² 37 / p 5e-10	4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Injection site pruritus	52	4.3 3.3–5.7ROR 4.4 · χ² 131 / p 1e-30	4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.7 · 92% clinician	no trial data cached
Muscle twitching	17	4.1 2.5–6.6ROR 4.1 · χ² 37 / p 7e-10	3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 55.2	no trial data cached
Injection site erythema (redness where injected)	67	3.0 2.4–3.8ROR 3.1 · χ² 89 / p 2e-21	3.0 EB05 2.4 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.1	no trial data cached
Injection site mass	20	3.0 1.9–4.7ROR 3.0 · χ² 25 / p 3e-7	2.9 EB05 2.0 · IC025 +0.8	Labeled (related wording) related wording	90% clinician	no trial data cached
Diplopia (double vision)	13	2.8 1.6–4.8ROR 2.8 · χ² 13 / p 1e-4	2.6 EB05 1.6 · IC025 +0.4	Labeled — boxed warning exact term	serious PRR 43.1	no trial data cached
Injection site rash	14	2.6 1.5–4.3ROR 2.6 · χ² 12 / p 3e-4	2.4 EB05 1.6 · IC025 +0.4	Labeled (related wording) related wording	serious n=1	no trial data cached
Eye swelling	17	2.6 1.6–4.1ROR 2.6 · χ² 15 / p 7e-5	2.4 EB05 1.6 · IC025 +0.5	Labeled (related wording) related wording	serious PRR 11.7	no trial data cached
Product storage error	39	2.5 1.8–3.4ROR 2.5 · χ² 34 / p 3e-9	2.5 EB05 1.9 · IC025 +0.8	Reporting / coding artifact	100% clinician	no trial data cached
Inappropriate schedule of product administration	72	2.3 1.8–2.8ROR 2.3 · χ² 50 / p 8e-13	2.2 EB05 1.8 · IC025 +0.8	Reporting / coding artifact	96% clinician	no trial data cached
Injection site pain (pain where injected)	114	2.1 1.7–2.5ROR 2.1 · χ² 64 / p 5e-16	2.1 EB05 1.8 · IC025 +0.7	Labeled (related wording) related wording	serious PRR 8.7	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)	1,589	6.7 6.5–7.0ROR 10.9 · χ² 8,223 / p <1e-300	6.7 EB05 6.4 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 2.2 · 91% clinician	no trial data cached
Off label use (used outside approved label)	1,314	8.4 8.1–8.8ROR 12.4 · χ² 8,944 / p <1e-300	8.4 EB05 8.0 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 7.5	no trial data cached
Therapeutic product effect decreased	715	91.0 85.1–97.2ROR 112.0 · χ² 62,614 / p <1e-300	89.3 EB05 83.9 · IC025 +6.3 3/3 methods agree	Reporting / coding artifact	94% clinician	no trial data cached
Drug effect less than expected	469	191.2 175.4–208.4ROR 218.2 · χ² 85,609 / p <1e-300	183.4 EB05 169.9 · IC025 +7.1 3/3 methods agree	Reporting / coding artifact	92% clinician	no trial data cached
Injection site pain (pain where injected)	114	2.1 1.7–2.5ROR 2.1 · χ² 64 / p 5e-16	2.1 EB05 1.8 · IC025 +0.7	Labeled (related wording) related wording	serious PRR 8.7	no trial data cached
Injection site swelling	99	7.3 6.0–8.8ROR 7.4 · χ² 530 / p 1e-117	7.1 EB05 6.0 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 69.9 · 91% clinician	no trial data cached
Eyelid ptosis	73	40.1 32.0–50.4ROR 40.9 · χ² 2,729 / p <1e-300	39.5 EB05 32.5 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious n=4	no trial data cached
Inappropriate schedule of product administration	72	2.3 1.8–2.8ROR 2.3 · χ² 50 / p 8e-13	2.2 EB05 1.8 · IC025 +0.8	Reporting / coding artifact	96% clinician	no trial data cached
Injection site erythema (redness where injected)	67	3.0 2.4–3.8ROR 3.1 · χ² 89 / p 2e-21	3.0 EB05 2.4 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.1	no trial data cached
Injection site pruritus	52	4.3 3.3–5.7ROR 4.4 · χ² 131 / p 1e-30	4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.7 · 92% clinician	no trial data cached
Product storage error	39	2.5 1.8–3.4ROR 2.5 · χ² 34 / p 3e-9	2.5 EB05 1.9 · IC025 +0.8	Reporting / coding artifact	100% clinician	no trial data cached
Injection site mass	20	3.0 1.9–4.7ROR 3.0 · χ² 25 / p 3e-7	2.9 EB05 2.0 · IC025 +0.8	Labeled (related wording) related wording	90% clinician	no trial data cached
Injection site bruising	18	1.3 0.8–2.0ROR 1.3 · χ² 1 / p 0.190	1.3 EB05 0.9 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Labeled (related wording) related wording	–	no trial data cached
Eye swelling	17	2.6 1.6–4.1ROR 2.6 · χ² 15 / p 7e-5	2.4 EB05 1.6 · IC025 +0.5	Labeled (related wording) related wording	serious PRR 11.7	no trial data cached
Muscle twitching	17	4.1 2.5–6.6ROR 4.1 · χ² 37 / p 7e-10	3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 55.2	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Prabotulinum Toxin Type A?

In FDA FAERS, the most frequently co-reported reaction terms for Prabotulinum Toxin Type A are injection site pain, injection site swelling, eyelid ptosis, injection site erythema, injection site pruritus, injection site mass. 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 Prabotulinum Toxin Type A have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: DISTANT SPREAD OF TOXIN EFFECT The effects of all botulinum toxin products, including JEUVEAU, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death.

Do FAERS signals prove that Prabotulinum Toxin Type A 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 17a914c1-e54b-4b50-965d-b0fd9111bba4, effective 20230428; matched on openfda.generic_name.exact:"PRABOTULINUM TOXIN TYPE A")
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, 25 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.