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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.

BOTOX COSMETIC: 1,839 Adverse Event Reports & Safety Profile

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1,839
Total FAERS Reports
0
Deaths Reported
8
Hospitalizations
1,839
As Primary/Secondary Suspect

First Report: 2003 · Latest Report: 20140505

What Are the Most Common BOTOX COSMETIC Side Effects?

#1 Most Reported
Drug ineffective
866 reports (47.1%)
#2 Most Reported
Off label use
421 reports (22.9%)
#3 Most Reported
Therapeutic response decreased
385 reports (20.9%)

All BOTOX COSMETIC Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 866 47.1% 0 0
Off label use 421 22.9% 0 1
Therapeutic response decreased 385 20.9% 0 0
Wrong technique in drug usage process 307 16.7% 0 1
Injection site pain 160 8.7% 0 0
Eyelid ptosis 109 5.9% 0 0
Headache 79 4.3% 0 1
Facial paresis 45 2.5% 0 0
Swelling face 41 2.2% 0 1
Injection site swelling 39 2.1% 0 0
Eye swelling 32 1.7% 0 1
Nausea 28 1.5% 0 0
Dizziness 27 1.5% 0 0
Eyelid oedema 26 1.4% 0 0
Vision blurred 25 1.4% 0 2
Injection site erythema 23 1.3% 0 0
Dyspnoea 22 1.2% 0 4
Brow ptosis 21 1.1% 0 0
Hypoaesthesia 21 1.1% 0 1
Dysphagia 20 1.1% 0 1

Who Reports BOTOX COSMETIC Side Effects? Age & Gender Data

Average age: 48.5 years. Most reports from: US. View detailed demographics →

Is BOTOX COSMETIC Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 0
2007 1 0 0
2010 6 0 0
2011 1 0 0
2012 17 0 1
2013 154 0 2
2014 5 0 1

View full timeline →

What Is BOTOX COSMETIC Used For?

IndicationReports
Skin wrinkling 1,723
Product used for unknown indication 95
Face lift 11
Hyperhidrosis 5

BOTOX COSMETIC vs Alternatives: Which Is Safer?

BOTOX COSMETIC vs BOTULINUM TOXIN NOS BOTOX COSMETIC vs BOTULINUM TOXIN TYPE A BOTOX COSMETIC vs BREMELANOTIDE BOTOX COSMETIC vs BRENTUXIMAB BOTOX COSMETIC vs BRENTUXIMAB VEDOTIN BOTOX COSMETIC vs BREO ELLIPTA BOTOX COSMETIC vs BREXANOLONE BOTOX COSMETIC vs BREXPIPRAZOLE BOTOX COSMETIC vs BREXUCABTAGENE AUTOLEUCEL BOTOX COSMETIC vs BRIGATINIB

Official FDA Label for BOTOX COSMETIC

Official prescribing information from the FDA-approved drug label.