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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

INCOBOTULINUMTOXINA: 4,823 Adverse Event Reports & Safety Profile

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4,823
Total FAERS Reports
76 (1.6%)
Deaths Reported
150
Hospitalizations
4,823
As Primary/Secondary Suspect
26
Life-Threatening
49
Disabilities
Prescription
Status

FDA Application: 125360 ·

First Report: 2006 · Latest Report: 20250911

What Are the Most Common INCOBOTULINUMTOXINA Side Effects?

#1 Most Reported
Drug ineffective
1,621 reports (33.6%)
#2 Most Reported
Off label use
1,127 reports (23.4%)
#3 Most Reported
Therapeutic response decreased
598 reports (12.4%)

All INCOBOTULINUMTOXINA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 1,621 33.6% 4 2
Off label use 1,127 23.4% 17 47
Therapeutic response decreased 598 12.4% 1 1
Injection site pain 300 6.2% 2 4
Product preparation issue 174 3.6% 0 3
Headache 164 3.4% 2 13
Injection site swelling 164 3.4% 1 3
Overdose 152 3.2% 3 4
Pain 145 3.0% 0 3
Eyelid ptosis 122 2.5% 3 7
Injection site mass 119 2.5% 0 0
Injection site erythema 107 2.2% 1 0
Burning sensation 95 2.0% 0 2
Incorrect route of product administration 95 2.0% 1 1
Dysphagia 93 1.9% 6 24
Swelling 87 1.8% 0 0
Erythema 83 1.7% 0 0
Product use in unapproved indication 79 1.6% 0 7
Dizziness 72 1.5% 2 14
Nausea 64 1.3% 1 10

Who Reports INCOBOTULINUMTOXINA Side Effects? Age & Gender Data

Gender: 85.3% female, 14.7% male. Average age: 49.0 years. Most reports from: US. View detailed demographics →

Is INCOBOTULINUMTOXINA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 0 0
2008 1 1 0
2009 27 0 0
2010 1 0 0
2011 1 0 0
2013 3 0 2
2014 14 0 4
2015 86 1 6
2016 52 0 2
2017 39 1 6
2018 72 3 5
2019 136 2 6
2020 185 1 6
2021 216 2 15
2022 258 7 12
2023 317 8 28
2024 267 9 13
2025 145 3 5

View full timeline →

What Is INCOBOTULINUMTOXINA Used For?

IndicationReports
Product used for unknown indication 2,309
Skin cosmetic procedure 1,128
Skin wrinkling 996
Torticollis 222
Muscle spasticity 125
Migraine 120
Neuromuscular blocking therapy 70
Blepharospasm 68
Salivary hypersecretion 52
Hemiplegia 49

INCOBOTULINUMTOXINA vs Alternatives: Which Is Safer?

INCOBOTULINUMTOXINA vs INDACATEROL INCOBOTULINUMTOXINA vs INDAPAMIDE INCOBOTULINUMTOXINA vs INDAPAMIDE\PERINDOPRIL INCOBOTULINUMTOXINA vs INDAPAMIDE\PERINDOPRIL ARGININE INCOBOTULINUMTOXINA vs INDAPAMIDE\PERINDOPRIL ERBUMINE INCOBOTULINUMTOXINA vs INDINAVIR INCOBOTULINUMTOXINA vs INDOMETHACIN INCOBOTULINUMTOXINA vs INDOMETHACIN\INDOMETHACIN INCOBOTULINUMTOXINA vs INEBILIZUMAB-CDON INCOBOTULINUMTOXINA vs INEXIUM

Official FDA Label for INCOBOTULINUMTOXINA

Official prescribing information from the FDA-approved drug label.