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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.

ABOBOTULINUMTOXINA: 5,789 Adverse Event Reports & Safety Profile

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5,789
Total FAERS Reports
109 (1.9%)
Deaths Reported
406
Hospitalizations
5,789
As Primary/Secondary Suspect
47
Life-Threatening
146
Disabilities
Prescription
Status

FDA Application: 125274 ·

First Report: 19990311 · Latest Report: 20250905

What Are the Most Common ABOBOTULINUMTOXINA Side Effects?

#1 Most Reported
Off label use
2,271 reports (39.2%)
#2 Most Reported
Drug ineffective
1,677 reports (29.0%)
#3 Most Reported
Product preparation error
751 reports (13.0%)

All ABOBOTULINUMTOXINA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 2,271 39.2% 29 115
Drug ineffective 1,677 29.0% 0 5
Product preparation error 751 13.0% 2 9
Headache 379 6.6% 1 37
Overdose 344 5.9% 2 16
Inappropriate schedule of drug administration 318 5.5% 1 8
Therapeutic response shortened 313 5.4% 0 1
Eyelid ptosis 301 5.2% 1 29
Injection site pain 278 4.8% 0 4
Muscular weakness 272 4.7% 2 63
Intentional product misuse 259 4.5% 0 4
Dysphagia 240 4.2% 5 84
Vision blurred 234 4.0% 1 30
Dyspnoea 194 3.4% 3 66
Dizziness 193 3.3% 0 34
Wrong technique in product usage process 186 3.2% 0 4
Fatigue 183 3.2% 1 38
Pain 175 3.0% 0 16
Nausea 174 3.0% 0 31
Asthenia 167 2.9% 1 51

Who Reports ABOBOTULINUMTOXINA Side Effects? Age & Gender Data

Gender: 87.3% female, 12.7% male. Average age: 46.6 years. Most reports from: US. View detailed demographics →

Is ABOBOTULINUMTOXINA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 2 0 0
2003 1 0 0
2004 3 0 0
2006 1 0 0
2007 1 0 0
2008 2 0 1
2009 7 0 3
2010 3 0 2
2011 22 0 1
2012 25 3 4
2013 14 1 3
2014 81 3 18
2015 140 7 31
2016 243 8 29
2017 304 6 26
2018 385 7 45
2019 268 6 24
2020 204 5 19
2021 338 11 26
2022 434 8 19
2023 469 4 31
2024 252 7 19
2025 112 3 22

View full timeline →

What Is ABOBOTULINUMTOXINA Used For?

IndicationReports
Skin wrinkling 2,890
Off label use 2,170
Skin cosmetic procedure 1,291
Muscle spasticity 595
Product used for unknown indication 419
Product use in unapproved indication 334
Torticollis 320
Product use issue 88
Hemiplegia 53
Dystonia 48

ABOBOTULINUMTOXINA vs Alternatives: Which Is Safer?

ABOBOTULINUMTOXINA vs ABRAXANE ABOBOTULINUMTOXINA vs ABROCITINIB ABOBOTULINUMTOXINA vs ACALABRUTINIB ABOBOTULINUMTOXINA vs ACAMPROSATE ABOBOTULINUMTOXINA vs ACARBOSE ABOBOTULINUMTOXINA vs ACCUTANE ABOBOTULINUMTOXINA vs ACEBUTOLOL ABOBOTULINUMTOXINA vs ACECLOFENAC ABOBOTULINUMTOXINA vs ACEMETACIN ABOBOTULINUMTOXINA vs ACENOCOUMAROL

Official FDA Label for ABOBOTULINUMTOXINA

Official prescribing information from the FDA-approved drug label.