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Inside MedSpa
Intelligence for Medical-Aesthetics Owners
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SAFETYTirzepatide (Mounjaro/Zepbound) — 140,435 adverse-event reportsFDA CLEAREDIntense Pulsed Light Therapy Device — Sanhe LEFIS Electronics Co., Ltd.Bausch Health (Solta) -8.71%SAFETYSemaglutide (Wegovy/Ozempic) — 82,911 adverse-event reportsFDA CLEAREDBarbed PDO Suture — Sutura Medical Technology, Inc.STRATA Skin Sciences +8.33%SAFETYBotox — 75,499 adverse-event reportsFDA CLEAREDERBECRYO 2 Cryosurgical Unit and Accessories — Erbe Elektromedizin GmbHThe Beauty Health Company (HydraFacial) -7.17%FDA CLEAREDLumiGlam Laser System (SHE-LSP601-3) — Beijing Sano Laser S&T Development Co.,LtdEli Lilly +7.04%FDA CLEAREDCurrentBody Skin LED Multi Light Therapy Mask (MK-110D) — The Beauty Tech Group, Ltd.STAAR Surgical -5.13%RECALLFDA recall: PAYLESS COMPOUNDERS, LLC — Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 RECALLFDA recall: HTO Nevada Inc. dba Kirkman — MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottRECALLFDA recall: Pro Numb Tattoo Numbing Spray LLC — Pro Numb Tattoo Numbing Spray, For Sensiti
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. 340,356 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

FAERS
75,499reports
19%serious
Most-reported reactions
Drug Ineffective 26,371
Off Label Use 11,277
Therapeutic Response Decreased 4,504
Headache 4,025
Product Preparation Error 3,655

Dysport

FAERS
6,783reports
29%serious
Most-reported reactions
Off Label Use 2,429
Drug Ineffective 1,806
Product Preparation Error 756
Headache 464
Muscular Weakness 371

Xeomin

FAERS
5,427reports
14%serious
Most-reported reactions
Drug Ineffective 1,785
Off Label Use 1,194
Therapeutic Response Decreased 695
Injection Site Pain 329
Product Preparation Issue 196

Jeuveau

FAERS
3,770reports
2%serious
Most-reported reactions
Drug Ineffective 1,587
Off Label Use 1,312
Therapeutic Product Effect Decreased 715
Drug Effect Less Than Expected 469
Headache 170

Daxxify

FAERS
46reports
41%serious
Most-reported reactions
Drug Ineffective 11
Eyelid Ptosis 6
Headache 6
Influenza Like Illness 4
Anxiety 3
Dermal filler

Juvederm

MAUDE
9,535reports
87%serious

Sculptra

MAUDE
1,984reports
52%serious

Radiesse

MAUDE
1,614reports
75%serious

Restylane

MAUDE
1,201reports
79%serious
Energy device

CoolSculpting

MAUDE
11,042reports
98%serious

Morpheus8

MAUDE
61reports
100%serious

Ultherapy

MAUDE
42reports
93%serious

Emsculpt

MAUDE
6reports
83%serious
GLP-1 (weight-loss demand driver)

Tirzepatide (Mounjaro/Zepbound)

FAERS
140,435reports
17%serious
Most-reported reactions
Incorrect Dose Administered 28,115
Nausea 14,290
Injection Site Pain 13,177
Extra Dose Administered 9,000
Diarrhoea 8,305

Semaglutide (Wegovy/Ozempic)

FAERS
82,911reports
54%serious
Most-reported reactions
Nausea 12,084
Vomiting 7,988
Off Label Use 7,322
Diarrhoea 6,943
Decreased Appetite 4,963

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.

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Source: 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.

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