Key statistics
- As of openFDA's July 30, 2026 update, FAERS held 39,057 adverse event reports naming Botox Cosmetic (2004-2026); 1,074 were coded serious, 283 involved hospitalization and 26 had death as an outcome - reports, not proven cases or rates. [1]
- The most common FAERS terms in Botox Cosmetic reports are 'drug ineffective' (20,375 reports) and 'off label use' (5,819); among side effects, eyelid ptosis appears in 1,908 reports and headache in 1,456 (2026 data). [2]
- FDA received 3,022 FAERS reports naming Botox Cosmetic in 2023, 1,565 in 2024 and 1,338 in 2025 (by FDA receipt date); yearly counts swing with manufacturer reporting practices, not just patient harm. [3]
- FAERS held 252 reports naming Letybo and 68 naming Daxxify (by reported product name) as of July 2026; none of the Letybo reports had a death outcome. [4]
- A 2026 analysis of aesthetic botulinum toxin reports (FAERS, EudraVigilance, Health Canada, Australia's TGA; 2002-2025) found 43,809 reports, 87.5% from FAERS; 57.3% concerned lack of effect, 19.7% injection-site reactions, 9.9% facial paresis/ptosis/asymmetry and 6.0% headache. [5]
How common are Botox side effects (eyelid droop, headache, bruising)?
As of openFDA's July 30, 2026 update, FAERS held 39,057 adverse event reports naming Botox Cosmetic (2004-2026); 1,074 were coded serious, 283 involved hospitalization and 26 had death as an outcome - reports, not proven cases or rates. [1]
The most common FAERS terms in Botox Cosmetic reports are 'drug ineffective' (20,375 reports) and 'off label use' (5,819); among side effects, eyelid ptosis appears in 1,908 reports and headache in 1,456 (2026 data). [2]
FDA received 3,022 FAERS reports naming Botox Cosmetic in 2023, 1,565 in 2024 and 1,338 in 2025 (by FDA receipt date); yearly counts swing with manufacturer reporting practices, not just patient harm. [3]
FAERS held 252 reports naming Letybo and 68 naming Daxxify (by reported product name) as of July 2026; none of the Letybo reports had a death outcome. [4]
A 2026 analysis of aesthetic botulinum toxin reports (FAERS, EudraVigilance, Health Canada, Australia's TGA; 2002-2025) found 43,809 reports, 87.5% from FAERS; 57.3% concerned lack of effect, 19.7% injection-site reactions, 9.9% facial paresis/ptosis/asymmetry and 6.0% headache. [5]
In that 2026 multi-database analysis, onabotulinumtoxinA (Botox) accounted for 86.8% of FAERS aesthetic-toxin reports with brand attribution, abobotulinumtoxinA (Dysport) 9.7% and incobotulinumtoxinA (Xeomin) 2.4% - largely reflecting market share, not relative risk. [5]
Cochrane also found major adverse events (eyelid ptosis, eyelid sensory disorder, strabismus) probably more frequent with Botox 20 units than placebo (Peto odds ratio 3.62; 8 studies, 1,390 participants), while any adverse event may not differ (RR 1.14) (2020 data). [6]
A 2016 meta-analysis of placebo-controlled trials found frown-line toxin injections raised the risk of eyelid ptosis (RR 5.56) and headache (RR 1.53) versus placebo, while crow's-feet injections showed no significant overall increase in adverse events except bruising (hematoma). [7]
A 2025 meta-analysis of 20 randomized trials (7,275 toxin-treated vs 2,552 placebo patients) found adverse events modestly more common with botulinum toxin A for facial lines (RR 1.22); by treatment area, the relative increase was largest for forehead lines (RR 1.53), then frown lines (RR 1.42) and crow's feet (RR 1.13) (2023 data). [8]
Find Botox providers near you
Compare Google ratings, reviews and posted prices at med spas in your city.
What these numbers can't tell you
- Counts are Google Maps listings we classify as med spas, so they include dermatology and plastic surgery practices that offer med spa treatments and exclude spas without a Google listing.
- A treatment counts when the spa's Google listing or website names it, so a spa with an outdated menu can be over- or under-counted.
- We hold no patient records: every figure describes providers, their listings and their Google reviews, not who gets treated.
Frequently asked questions
How common are Botox side effects (eyelid droop, headache, bruising)?
As of openFDA's July 30, 2026 update, FAERS held 39,057 adverse event reports naming Botox Cosmetic (2004-2026); 1,074 were coded serious, 283 involved hospitalization and 26 had death as an outcome - reports, not proven cases or rates.
Sources and methodology
Our data. October 2026 snapshot of 53,215 US med spa Google listings and their websites. How we build these numbers
- api.fda.gov · U.S. Food and Drug Administration
- api.fda.gov · U.S. Food and Drug Administration
- api.fda.gov · U.S. Food and Drug Administration
- api.fda.gov · U.S. Food and Drug Administration
- pubmed.ncbi.nlm.nih.gov · National Library of Medicine
- pubmed.ncbi.nlm.nih.gov · National Library of Medicine
- pubmed.ncbi.nlm.nih.gov · National Library of Medicine
- pubmed.ncbi.nlm.nih.gov · National Library of Medicine
MedSpaStandard. (2026, October 30). Botox Safety Statistics 2026. https://medspastandard.com/statistics/botox/safety/
Medical disclaimer. MedSpaStandard is for education only and is not medical advice. Talk to a licensed provider about your own health, and check any provider's license with your state board.