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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.

ONABOTULINUMTOXINA: 49,218 Adverse Event Reports & Safety Profile

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49,218
Total FAERS Reports
1,489 (3.0%)
Deaths Reported
2,307
Hospitalizations
49,218
As Primary/Secondary Suspect
273
Life-Threatening
603
Disabilities
Prescription
Status

FDA Application: 103000 ·

First Report: 101911 · Latest Report: 21091216

What Are the Most Common ONABOTULINUMTOXINA Side Effects?

#1 Most Reported
Drug ineffective
18,179 reports (36.9%)
#2 Most Reported
Off label use
9,698 reports (19.7%)
#3 Most Reported
Product preparation error
3,593 reports (7.3%)

All ONABOTULINUMTOXINA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 18,179 36.9% 57 173
Off label use 9,698 19.7% 181 331
Product preparation error 3,593 7.3% 1 14
Multiple use of single-use product 2,781 5.7% 2 4
Therapeutic response decreased 2,685 5.5% 0 8
Headache 2,316 4.7% 15 205
Injection site pain 2,143 4.4% 1 34
Eyelid ptosis 1,853 3.8% 2 69
Wrong technique in product usage process 1,477 3.0% 0 7
Migraine 1,232 2.5% 24 172
Death 1,153 2.3% 1,112 19
Pain 1,080 2.2% 50 129
Muscular weakness 1,066 2.2% 53 192
Dysphagia 1,020 2.1% 26 215
Nausea 1,014 2.1% 41 152
Dizziness 985 2.0% 12 165
Therapeutic response shortened 907 1.8% 0 14
Vision blurred 855 1.7% 1 113
Dyspnoea 817 1.7% 31 207
Fatigue 800 1.6% 16 137

Who Reports ONABOTULINUMTOXINA Side Effects? Age & Gender Data

Gender: 87.0% female, 13.0% male. Average age: 49.3 years. Most reports from: US. View detailed demographics →

Is ONABOTULINUMTOXINA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 2 1 0
2001 10 9 0
2002 5 1 1
2003 5 2 0
2004 8 0 1
2005 5 1 0
2006 11 1 0
2007 15 3 6
2008 17 1 2
2009 44 2 2
2010 21 1 5
2011 34 2 5
2012 70 3 11
2013 141 13 16
2014 740 12 71
2015 1,525 27 81
2016 1,760 27 124
2017 1,601 26 136
2018 2,032 29 128
2019 2,250 45 157
2020 1,882 36 115
2021 1,357 42 96
2022 1,348 51 100
2023 1,415 113 164
2024 1,257 66 158
2025 801 60 108

View full timeline →

What Is ONABOTULINUMTOXINA Used For?

IndicationReports
Skin wrinkling 20,952
Product used for unknown indication 11,651
Migraine 6,443
Muscle spasticity 1,156
Torticollis 1,009
Hypertonic bladder 736
Skin cosmetic procedure 735
Hyperhidrosis 508
Blepharospasm 348
Muscle hypertrophy 348

ONABOTULINUMTOXINA vs Alternatives: Which Is Safer?

ONABOTULINUMTOXINA vs ONASEMNOGENE ABEPARVOVEC ONABOTULINUMTOXINA vs ONASEMNOGENE ABEPARVOVEC-XIOI ONABOTULINUMTOXINA vs ONBREZ ONABOTULINUMTOXINA vs ONDANSETRON ONABOTULINUMTOXINA vs ONFI ONABOTULINUMTOXINA vs OPANA ONABOTULINUMTOXINA vs OPICAPONE ONABOTULINUMTOXINA vs OPIPRAMOL ONABOTULINUMTOXINA vs OPIUM ONABOTULINUMTOXINA vs OPSUMIT

Official FDA Label for ONABOTULINUMTOXINA

Official prescribing information from the FDA-approved drug label.