Incobotulinumtoxina side effects: what 5,628 FDA adverse event reports show

Incobotulinumtoxina · Xeomin · 89 reaction terms · 7,174 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

Xeomin

openFDA label

Who reports

5,628 reports · 14% serious · 102 with death outcome · 84% female

openFDA FAERS counts, all years, deduplication not applied

Used for

XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of: Chronic sialorrhea in patients 2 years of age and older ( 1.1 ) Upper limb spasticity in patients 2 years of age and older ( 1..

FDA label, Indications and Usage

What it is

The active ingredient of XEOMIN is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A. The botulinum toxin complex is purified from the culture s.

FDA label, Description section

Boxed warning

DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects.

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 40 strongest signals

Labeled — boxed warning 3Labeled adverse reaction 8Labeled (related wording) 9Reporting / coding artifact 10Not in label — unassessed 10

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. 49 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
Eyelid ptosis	130	48.2 40.6–57.2ROR 49.3 · χ² 5,891 / p <1e-300	47.3 EB05 40.9 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=21	no trial data cached
Therapeutic response decreased	733	45.8 42.8–49.1ROR 52.6 · χ² 31,799 / p <1e-300	45.2 EB05 42.6 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	serious PRR 6.7 · 94% clinician	no trial data cached
Incorrect route of product administration	108	24.1 20.0–29.1ROR 24.5 · χ² 2,354 / p <1e-300	23.9 EB05 20.3 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 9.4 · 93% clinician	no trial data cached
Mass	52	13.9 10.6–18.2ROR 14.0 · χ² 606 / p 3e-134	13.6 EB05 10.7 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.6 · 92% clinician	no trial data cached
Injection site mass	130	13.2 11.1–15.6ROR 13.5 · χ² 1,449 / p <1e-300	13.1 EB05 11.3 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.9 · 93% clinician	no trial data cached
Tenderness	36	12.9 9.3–17.9ROR 13.0 · χ² 382 / p 3e-85	12.5 EB05 9.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	94% clinician	no trial data cached
Injection site swelling	203	10.0 8.7–11.5ROR 10.3 · χ² 1,638 / p <1e-300	9.9 EB05 8.8 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.6 · 92% clinician	no trial data cached
Injection site nodule	26	8.8 6.0–13.0ROR 8.9 · χ² 173 / p 1e-39	8.0 EB05 5.6 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Nodule	26	7.4 5.1–10.9ROR 7.5 · χ² 138 / p 3e-32	6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 13.2	no trial data cached
Therapy partial responder	28	6.9 4.8–10.0ROR 7.0 · χ² 136 / p 9e-32	6.3 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 35.8 · ♀ 0% (drug 84%) · 96% clinician	no trial data cached
Injection site induration	23	6.6 4.4–10.0ROR 6.6 · χ² 104 / p 1e-24	5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious n=5 · 90% clinician	no trial data cached
Eyelid oedema	19	6.1 3.9–9.5ROR 6.1 · χ² 75 / p 2e-18	5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.0	no trial data cached
Paralysis	21	5.5 3.6–8.4ROR 5.5 · χ² 72 / p 1e-17	4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 16.1	no trial data cached
Burning sensation	102	5.4 4.5–6.6ROR 5.5 · χ² 365 / p 1e-81	5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.0 · 98% clinician	no trial data cached
Injection site urticaria	34	5.2 3.7–7.3ROR 5.3 · χ² 112 / p 2e-26	4.9 EB05 3.7 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	94% clinician	no trial data cached
Drug ineffective (drug did not work)	1,836	5.2 5.0–5.4ROR 7.2 · χ² 6,635 / p <1e-300	5.2 EB05 5.0 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 1.0 · 92% clinician	no trial data cached
Off label use (used outside approved label)	1,205	5.2 4.9–5.4ROR 6.3 · χ² 4,229 / p <1e-300	5.2 EB05 4.9 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 7.4	no trial data cached
Dysphagia (difficulty swallowing)	121	4.8 4.0–5.7ROR 4.9 · χ² 358 / p 5e-80	4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 17.4	no trial data cached
Swelling	108	4.3 3.6–5.2ROR 4.4 · χ² 272 / p 2e-61	4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.7	no trial data cached
Underdose	83	4.2 3.4–5.2ROR 4.3 · χ² 202 / p 3e-46	4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 1.7 · 99% clinician	no trial data cached
Diplopia (double vision)	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	Labeled — boxed warning exact term	serious PRR 12.6	no trial data cached
Injection site pain (pain where injected)	333	4.1 3.7–4.5ROR 4.3 · χ² 785 / p 5e-173	4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.8 · 90% clinician	no trial data cached
Injection site erythema (redness where injected)	132	4.0 3.4–4.7ROR 4.1 · χ² 294 / p 4e-66	3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.2 · 94% clinician	no trial data cached
Rash papular	24	4.0 2.7–5.9ROR 4.0 · χ² 51 / p 5e-13	3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	91% clinician	no trial data cached
Drug resistance	27	3.9 2.7–5.7ROR 3.9 · χ² 56 / p 4e-14	3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 0.7	no trial data cached
Overdose	202	3.5 3.0–4.0ROR 3.6 · χ² 357 / p 6e-80	3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 1.4	no trial data cached
Muscle tightness	15	3.5 2.1–5.7ROR 3.5 · χ² 24 / p 5e-7	3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Injection site rash	26	3.2 2.2–4.7ROR 3.2 · χ² 37 / p 6e-10	3.1 EB05 2.2 · IC025 +1.0 3/3 methods agree	Labeled (related wording) related wording	serious n=9	no trial data cached
Eye swelling	31	3.1 2.2–4.4ROR 3.1 · χ² 43 / p 3e-11	3.0 EB05 2.2 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.8	no trial data cached
Neck pain	42	2.8 2.1–3.8ROR 2.8 · χ² 47 / p 4e-12	2.7 EB05 2.1 · IC025 +0.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.2	no trial data cached
Influenza like illness (flu-like illness)	62	2.8 2.2–3.6ROR 2.8 · χ² 70 / p 3e-17	2.8 EB05 2.2 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 15.1	no trial data cached
Head discomfort	13	2.8 1.6–4.7ROR 2.8 · χ² 13 / p 2e-4	2.6 EB05 1.6 · IC025 +0.4	Labeled (related wording) related wording	serious PRR 14.4	no trial data cached
Hypoaesthesia oral	11	2.7 1.5–4.9ROR 2.7 · χ² 10 / p 7e-4	2.5 EB05 1.5 · IC025 +0.3	Not in label — unassessed	serious PRR 13.5	no trial data cached
Product use in unapproved indication	171	2.6 2.3–3.0ROR 2.7 · χ² 170 / p 4e-39	2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 8.0 · ♀ 41% (drug 84%)	no trial data cached
Muscle twitching	16	2.6 1.6–4.2ROR 2.6 · χ² 14 / p 9e-5	2.5 EB05 1.6 · IC025 +0.5	Not in label — unassessed	serious PRR 4.3	no trial data cached
Muscular weakness	74	2.4 1.9–3.0ROR 2.4 · χ² 61 / p 3e-15	2.4 EB05 2.0 · IC025 +0.9	Labeled adverse reaction exact term	serious PRR 9.2	no trial data cached
Choking	12	2.3 1.3–4.1ROR 2.3 · χ² 8 / p 0.003	2.2 EB05 1.4 · IC025 +0.2	Not in label — unassessed	serious PRR 9.6	no trial data cached
Injection site pruritus	38	2.1 1.5–2.9ROR 2.1 · χ² 22 / p 2e-6	2.1 EB05 1.6 · IC025 +0.5	Labeled (related wording) related wording	serious PRR 5.0	no trial data cached
Drug effect decreased	31	2.1 1.5–3.0ROR 2.1 · χ² 17 / p 2e-5	2.1 EB05 1.5 · IC025 +0.5	Reporting / coding artifact	serious PRR 1.0	no trial data cached
Vision blurred (blurred vision)	77	2.1 1.7–2.6ROR 2.1 · χ² 44 / p 2e-11	2.1 EB05 1.7 · IC025 +0.7	Labeled — boxed warning synonym match	serious PRR 6.2	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)	1,836	5.2 5.0–5.4ROR 7.2 · χ² 6,635 / p <1e-300	5.2 EB05 5.0 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 1.0 · 92% clinician	no trial data cached
Off label use (used outside approved label)	1,205	5.2 4.9–5.4ROR 6.3 · χ² 4,229 / p <1e-300	5.2 EB05 4.9 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 7.4	no trial data cached
Therapeutic response decreased	733	45.8 42.8–49.1ROR 52.6 · χ² 31,799 / p <1e-300	45.2 EB05 42.6 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	serious PRR 6.7 · 94% clinician	no trial data cached
Injection site pain (pain where injected)	333	4.1 3.7–4.5ROR 4.3 · χ² 785 / p 5e-173	4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.8 · 90% clinician	no trial data cached
Injection site swelling	203	10.0 8.7–11.5ROR 10.3 · χ² 1,638 / p <1e-300	9.9 EB05 8.8 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.6 · 92% clinician	no trial data cached
Overdose	202	3.5 3.0–4.0ROR 3.6 · χ² 357 / p 6e-80	3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 1.4	no trial data cached
Product use in unapproved indication	171	2.6 2.3–3.0ROR 2.7 · χ² 170 / p 4e-39	2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 8.0 · ♀ 41% (drug 84%)	no trial data cached
Injection site erythema (redness where injected)	132	4.0 3.4–4.7ROR 4.1 · χ² 294 / p 4e-66	3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.2 · 94% clinician	no trial data cached
Injection site mass	130	13.2 11.1–15.6ROR 13.5 · χ² 1,449 / p <1e-300	13.1 EB05 11.3 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.9 · 93% clinician	no trial data cached
Eyelid ptosis	130	48.2 40.6–57.2ROR 49.3 · χ² 5,891 / p <1e-300	47.3 EB05 40.9 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=21	no trial data cached
Dysphagia (difficulty swallowing)	121	4.8 4.0–5.7ROR 4.9 · χ² 358 / p 5e-80	4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 17.4	no trial data cached
Swelling	108	4.3 3.6–5.2ROR 4.4 · χ² 272 / p 2e-61	4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.7	no trial data cached
Incorrect route of product administration	108	24.1 20.0–29.1ROR 24.5 · χ² 2,354 / p <1e-300	23.9 EB05 20.3 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 9.4 · 93% clinician	no trial data cached
Burning sensation	102	5.4 4.5–6.6ROR 5.5 · χ² 365 / p 1e-81	5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.0 · 98% clinician	no trial data cached
Erythema (skin redness)	91	1.7 1.3–2.0ROR 1.7 · χ² 23 / p 8e-7	1.6 EB05 1.4 · IC025 +0.4	Labeled adverse reaction exact term	serious PRR 0.8 · 96% clinician	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.

Tenderness — n=36, PRR 12.9
Nodule — n=26, PRR 7.4
Paralysis — n=21, PRR 5.5
Burning sensation — n=102, PRR 5.4
Rash papular — n=24, PRR 4.0
Influenza like illness — n=62, PRR 2.8

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 Incobotulinumtoxina?

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

Yes. The current FDA label carries a boxed warning: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects.

Do FAERS signals prove that Incobotulinumtoxina 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 3f35d6e0-3450-4abc-a0da-cc7b277e7c6e, effective 20260710; matched on openfda.generic_name.exact:"INCOBOTULINUMTOXINA")
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, 89 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.