BOTOX: 853 Adverse Event Reports & Safety Profile
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853
Total FAERS Reports
19 (2.2%)
Deaths Reported
51
Hospitalizations
853
As Primary/Secondary Suspect
4
Life-Threatening
17
Disabilities
First Report: 2001 · Latest Report: 20140615
What Are the Most Common BOTOX Side Effects?
#1 Most Reported
Off label use
175 reports (20.5%)
#2 Most Reported
Drug ineffective
162 reports (19.0%)
#3 Most Reported
Dysphagia
72 reports (8.4%)
All BOTOX Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 175 | 20.5% | 5 | 12 |
| Drug ineffective | 162 | 19.0% | 0 | 1 |
| Dysphagia | 72 | 8.4% | 1 | 13 |
| Muscular weakness | 65 | 7.6% | 0 | 8 |
| Headache | 64 | 7.5% | 0 | 3 |
| Eyelid ptosis | 49 | 5.7% | 0 | 1 |
| Therapeutic response decreased | 49 | 5.7% | 0 | 0 |
| Wrong technique in drug usage process | 48 | 5.6% | 0 | 0 |
| Neck pain | 44 | 5.2% | 0 | 2 |
| Injection site pain | 43 | 5.0% | 0 | 1 |
| Dyspnoea | 35 | 4.1% | 0 | 7 |
| Pain | 35 | 4.1% | 0 | 4 |
| Influenza like illness | 33 | 3.9% | 0 | 1 |
| Asthenia | 32 | 3.8% | 0 | 7 |
| Dry mouth | 31 | 3.6% | 0 | 2 |
| Dizziness | 28 | 3.3% | 0 | 3 |
| Rash | 26 | 3.1% | 0 | 0 |
| Vision blurred | 26 | 3.1% | 0 | 3 |
| Facial paresis | 23 | 2.7% | 0 | 1 |
| Musculoskeletal stiffness | 23 | 2.7% | 0 | 3 |
Who Reports BOTOX Side Effects? Age & Gender Data
Average age: 51.3 years. Most reports from: US. View detailed demographics →
Is BOTOX Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 0 |
| 2002 | 1 | 0 | 0 |
| 2005 | 1 | 0 | 1 |
| 2007 | 1 | 1 | 1 |
| 2008 | 1 | 0 | 0 |
| 2009 | 4 | 0 | 0 |
| 2010 | 5 | 0 | 3 |
| 2011 | 14 | 0 | 1 |
| 2012 | 48 | 5 | 3 |
| 2013 | 155 | 4 | 16 |
| 2014 | 42 | 3 | 12 |
What Is BOTOX Used For?
| Indication | Reports |
|---|---|
| Migraine | 235 |
| Skin wrinkling | 201 |
| Product used for unknown indication | 78 |
| Torticollis | 75 |
| Muscle spasticity | 39 |
| Muscle spasms | 33 |
| Hyperhidrosis | 31 |
| Blepharospasm | 30 |
| Drooling | 18 |
| Facial spasm | 13 |
BOTOX vs Alternatives: Which Is Safer?
BOTOX vs BOTOX COSMETIC
BOTOX vs BOTULINUM TOXIN NOS
BOTOX vs BOTULINUM TOXIN TYPE A
BOTOX vs BREMELANOTIDE
BOTOX vs BRENTUXIMAB
BOTOX vs BRENTUXIMAB VEDOTIN
BOTOX vs BREO ELLIPTA
BOTOX vs BREXANOLONE
BOTOX vs BREXPIPRAZOLE
BOTOX vs BREXUCABTAGENE AUTOLEUCEL
Official FDA Label for BOTOX
Official prescribing information from the FDA-approved drug label.