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. 380,169 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
FAERS78,038reports
20%serious
Most-reported reactions
Drug Ineffective
26,747
Off Label Use
11,678
Therapeutic Response Decreased
4,512
Headache
4,150
Product Preparation Error
3,646
Dysport
FAERS6,992reports
30%serious
Most-reported reactions
Off Label Use
2,523
Drug Ineffective
1,819
Product Preparation Error
757
Headache
479
Muscular Weakness
388
Xeomin
FAERS5,811reports
13%serious
Most-reported reactions
Drug Ineffective
1,876
Off Label Use
1,218
Therapeutic Response Decreased
761
Injection Site Pain
343
Overdose
237
Jeuveau
FAERS3,779reports
2%serious
Most-reported reactions
Drug Ineffective
1,590
Off Label Use
1,315
Therapeutic Product Effect Decreased
715
Drug Effect Less Than Expected
469
Headache
171
Daxxify
FAERS75reports
32%serious
Most-reported reactions
Rash Papular
19
Drug Ineffective
13
Headache
8
Eyelid Ptosis
6
Anxiety
4
Dermal filler
Juvederm
MAUDE10,024reports
88%serious
Sculptra
MAUDE2,038reports
53%serious
Radiesse
MAUDE1,678reports
76%serious
Restylane
MAUDE1,242reports
80%serious
Energy device
CoolSculpting
MAUDE11,288reports
98%serious
Morpheus8
MAUDE65reports
100%serious
Ultherapy
MAUDE42reports
93%serious
Emsculpt
MAUDE6reports
83%serious
GLP-1 (weight-loss demand driver)
Tirzepatide (Mounjaro/Zepbound)
FAERS181,068reports
18%serious
Most-reported reactions
Incorrect Dose Administered
32,155
Nausea
19,738
Injection Site Pain
14,616
Diarrhoea
11,312
Extra Dose Administered
10,288
Semaglutide (Wegovy/Ozempic)
FAERS78,023reports
50%serious
Most-reported reactions
Nausea
11,150
Off Label Use
7,890
Vomiting
7,332
Diarrhoea
6,833
Decreased Appetite
5,107
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.
Get the free briefSource: 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.