Compliance · Live FDA data
Aesthetic Safety Signals
Adverse-event report counts for the injectables, fillers, and devices you use — pulled from the FDA's FAERS (drugs) and MAUDE (devices) databases. 352,741 reports tracked across 15 products.
Read these carefully — they are signals, not verdicts. An adverse-event report does not prove the product caused the event. Counts are not adjusted for how widely a product is used, anyone can file a report, and totals reflect all reported history. Use this to know what to watch and ask about — not to rank products.
Neurotoxin
Botox
FAERS76,811reports
20%serious
Most-reported reactions
Drug Ineffective
26,576
Off Label Use
11,500
Therapeutic Response Decreased
4,510
Headache
4,097
Product Preparation Error
3,647
Dysport
FAERS6,882reports
30%serious
Most-reported reactions
Off Label Use
2,470
Drug Ineffective
1,812
Product Preparation Error
756
Headache
472
Muscular Weakness
384
Xeomin
FAERS5,621reports
13%serious
Most-reported reactions
Drug Ineffective
1,836
Off Label Use
1,205
Therapeutic Response Decreased
733
Injection Site Pain
333
Product Preparation Issue
207
Jeuveau
FAERS3,775reports
2%serious
Most-reported reactions
Drug Ineffective
1,589
Off Label Use
1,314
Therapeutic Product Effect Decreased
715
Drug Effect Less Than Expected
469
Headache
171
Daxxify
FAERS68reports
32%serious
Most-reported reactions
Rash Papular
19
Drug Ineffective
11
Eyelid Ptosis
6
Headache
6
Anxiety
4
Dermal filler
Juvederm
MAUDE9,792reports
88%serious
Sculptra
MAUDE2,009reports
52%serious
Radiesse
MAUDE1,641reports
76%serious
Restylane
MAUDE1,217reports
80%serious
Energy device
CoolSculpting
MAUDE11,149reports
98%serious
Morpheus8
MAUDE64reports
100%serious
Ultherapy
MAUDE42reports
93%serious
Emsculpt
MAUDE6reports
83%serious
GLP-1 (weight-loss demand driver)
Tirzepatide (Mounjaro/Zepbound)
FAERS160,663reports
18%serious
Most-reported reactions
Incorrect Dose Administered
29,672
Nausea
17,092
Injection Site Pain
13,906
Diarrhoea
10,006
Extra Dose Administered
9,608
Semaglutide (Wegovy/Ozempic)
FAERS73,001reports
50%serious
Most-reported reactions
Nausea
10,674
Off Label Use
7,325
Vomiting
6,964
Diarrhoea
6,462
Decreased Appetite
4,905
When a safety signal turns into a recall, know first.
We watch these databases continuously. Inside MedSpa Pro flags the moment a product you use spikes, gets a warning, or hits a recall — and what to do about it.
Go Pro · $20/moSource: openFDA FAERS & MAUDE. General information only — not medical, safety, or regulatory advice. Inside MedSpa is a general, impersonal publication for medical-aesthetics business owners. It is not individualized business, financial, medical, or legal advice. Any market or company information is general in nature and not a recommendation.