Injectable safety by product: what FAERS data reveals about neurotoxins and fillers

Patients comparing Botox, Dysport, Xeomin, Jeuveau, and Daxxify often ask which is "safest." The honest answer is that all five share the same active mechanism — botulinum toxin type A (or type B, for Myobloc) — and their safety profiles overlap substantially. But the FDA Adverse Event Reporting System (FAERS) does reveal meaningful differences in what gets reported, which adverse events appear most often for each brand, and how serious those reports tend to be.

An analysis of 98,626 FAERS reports captured for aesthetic injectable brands — covering neurotoxins (Botox, Dysport, Xeomin, Jeuveau, Daxxify, Myobloc), hyaluronic acid fillers (Juvéderm, Restylane, Voluma, Volbella, Belotero), and other injectables (Sculptra, Radiesse, Kybella) — provides a data-driven snapshot of postmarket safety signals.

This article breaks down the FAERS data by brand, event volume, seriousness, and reaction type. It explains what the numbers can and cannot tell you about real-world safety — and why comparing raw event counts across products without adjusting for market share produces misleading conclusions.

What FAERS is and what it is not

FAERS is the FDA's postmarket surveillance database for drug adverse events. It collects reports from manufacturers (who are required to submit serious events), healthcare professionals, and consumers. It is a spontaneous-reporting system, which means:

• Under-reporting is significant. Studies estimate that FAERS captures 10% or fewer of actual adverse events. A product with more FAERS reports is not necessarily more dangerous — it may simply be more widely used, have more manufacturer-mandated reporting, or have higher public awareness.
• Reports do not prove causation. A FAERS entry records that an event occurred after a drug was used; it does not establish that the drug caused the event. Many Botox FAERS reports, for example, involve patients who received Botox for therapeutic indications (migraine, spasticity, hyperhidrosis) with multiple concurrent medications.
• Seriousness classifications are broad. A "serious" event in FAERS means hospitalization, disability, a life-threatening condition, congenital anomaly, or death — or an event the reporter considers medically significant. The threshold is low, and the majority of "serious" events in the aesthetic-injectable data are classified under "other," not hospitalization or death.

With those caveats established, the data still provides useful signal — particularly when comparing reaction profiles between products in the same class.

Event volume by brand

Analysis of FAERS data, covering reports received from 2004 through early 2026.

Why Botox dominates the count

Botox (onabotulinumtoxinA) accounts for 77% of all aesthetic-injectable FAERS reports. This is primarily a function of market share: Botox has been on the market since 1989 (therapeutic) and 2002 (cosmetic), and it remains the highest-volume aesthetic injectable in the United States by a wide margin. With over 9 million neuromodulator procedures performed annually — the majority still Botox — even a low adverse-event rate generates large absolute numbers.

Why Daxxify's serious-event rate appears elevated

Daxxify (daxibotulinumtoxinA-lanm) shows 88.3% serious-event classification, dramatically higher than Botox (19.3%) or Xeomin (14.9%). This does not mean Daxxify is more dangerous. Several factors contribute:

1. Small sample size with reporting bias. With only 3,433 total reports, a small number of clustered reports can dramatically shift percentages. A 2023 spike of reports (potentially driven by a manufacturer reporting batch or a media event) accounts for a disproportionate share.
2. Therapeutic-indication mix. Daxxify received FDA approval for cervical dystonia and was later approved for glabellar lines. FAERS reports for therapeutic indications often carry higher seriousness rates because the patient population is sicker and has more comorbidities.
3. New-product scrutiny. Newer products often receive more diligent reporting from manufacturers during early postmarket surveillance.

Serious outcomes by brand

Among the serious-event reports, the breakdown of specific outcome types reveals additional context:

The death figures warrant specific context. Botox's 2,039 death reports span over two decades and predominantly involve therapeutic uses (cervical dystonia, spasticity, migraine) in medically complex patients — often with multiple concurrent drugs. These are not cosmetic-injection deaths in healthy patients. The same applies to Dysport and Xeomin.

For cosmetic aesthetic injections specifically, the most common serious outcomes are localized: eyelid ptosis, diplopia, dysphagia, facial asymmetry, and injection-site reactions requiring medical evaluation.

Top reactions: neurotoxins

The reaction profiles differ between products in instructive ways.

Botox — top 10 reported reactions

1. Drug ineffective (22,588)
2. Off-label use (11,764)
3. Therapeutic response decreased (3,757)
4. Product preparation error (3,676)
5. Headache (3,657)
6. Injection site pain (3,054)
7. Multiple use of single-use product (2,824)
8. Eyelid ptosis (2,366)
9. Migraine (2,320)
10. Nausea (1,998)

The dominance of "drug ineffective" and "off-label use" is notable. These are not traditional adverse reactions — they are reports of treatment failure or use outside the FDA-approved indication. Together they account for nearly half of all Botox reports. This reflects FAERS's broad capture: any unsatisfactory experience with a drug can be reported, not just harmful events.

Eyelid ptosis at #8 (2,366 reports) is the most clinically relevant aesthetic complication in the dataset. Ptosis occurs when neuromodulator diffuses into the levator palpebrae superioris, causing temporary drooping of the upper eyelid. It is the most well-known localized adverse event of cosmetic botulinum toxin and typically resolves within weeks.

Dysport — top 10 reported reactions

1. Off-label use (3,825)
2. Drug ineffective (3,261)
3. Headache (980)
4. Product use in unapproved indication (973)
5. Nausea (941)
6. Migraine (935)
7. Drug intolerance (720)
8. Product preparation error (714)
9. Pain (696)
10. Hyperhidrosis (552)

Dysport's reaction profile mirrors Botox's, with "off-label use" and "drug ineffective" leading. The relatively high reports of hyperhidrosis (#10) reflect Dysport's therapeutic use for excessive sweating.

Xeomin — top 10 reported reactions

1. Drug ineffective (2,056)
2. Off-label use (1,464)
3. Therapeutic response decreased (804)
4. Injection site pain (402)
5. Product preparation issue (222)
6. Headache (216)
7. Injection site swelling (207)
8. Pain (205)
9. Product use in unapproved indication (203)
10. Overdose (188)

Xeomin's profile is distinct in two ways: injection-site reactions (pain, swelling) rank higher, and "overdose" appears in the top 10 (188 reports). Overdose reports in FAERS for botulinum toxin typically reflect perceived excessive dosing rather than acute toxicity — patients or providers reporting that more units were administered than intended.

Top reactions: fillers

Juvéderm — top 10 reported reactions

1. Off-label use (258)
2. Drug ineffective (218)
3. Swelling face (120)
4. Headache (81)
5. Eyelid ptosis (81)
6. Contusion (78)
7. Erythema (62)
8. Facial paresis (55)
9. Therapeutic response decreased (55)
10. Injection site pain (54)

The filler reaction profile is markedly different from the neurotoxin profile. Swelling, contusion, and erythema reflect the physical presence of a volume-adding product. Facial paresis (#8, 55 reports) is a notable signal — it indicates cases where filler injection caused temporary nerve compression or muscle weakness, typically through compression of the facial nerve branches.

Restylane — top 10 reported reactions

1. Off-label use (129)
2. Product preparation error (34)
3. Drug ineffective (32)
4. Swelling face (28)
5. Swelling (25)
6. Injection site mass (25)
7. Injection site pain (22)
8. Eyelid ptosis (20)
9. Injection site swelling (20)
10. Erythema (19)

Restylane's profile shows a higher proportion of injection-site mass and swelling reports relative to total events — consistent with the NASHA (non-animal stabilized hyaluronic acid) gel technology, which tends to have a firmer, more lifting quality.

Year-over-year trends

FAERS report volume has been rising across all neuromodulators, driven by expanding use and improved reporting:

Botox report volume peaked at 7,712 in 2023, a 46% increase over 2022. This surge likely reflects both genuine reporting increases and manufacturer compliance with postmarket surveillance obligations.

Jeuveau's report volume dropped sharply from 1,185 in its launch year (2019) to under 500 in subsequent years — partly because initial launch-period reporting enthusiasm waned, and partly because the product experienced manufacturing-related supply interruptions.

What patients should take from this

1. Event count does not equal risk. Botox's 76,000 reports reflect 20+ years on the market and over 9 million annual procedures. Its serious-event rate (19%) is moderate for the class.
2. The most common "adverse events" are treatment dissatisfaction, not injury. "Drug ineffective" and "off-label use" dominate every product's report list. These are not safety failures.
3. Localized reactions — ptosis, swelling, bruising — are the real cosmetic risk. Serious systemic events are rare in the aesthetic-injection population.
4. FAERS data for fillers shows swelling, nodules, and vascular concerns. If you are considering fillers, ask your injector about their hyaluronidase protocol (for dissolving HA filler in an emergency) and their vascular anatomy training.

Limitations

• FAERS is a passive surveillance system with significant under-reporting; the absolute numbers understate real-world adverse events.
• Many reports involve therapeutic (non-cosmetic) use, especially for Botox, Dysport, and Xeomin, which have large spasticity and migraine populations.
• Report volume is influenced by market share, time on market, manufacturer reporting practices, and media attention — not just product safety.
• No adjustment has been made for total units sold or total patients treated, so per-patient or per-unit rates cannot be calculated from FAERS data alone.

Sources

• FDA Adverse Event Reporting System (FAERS) public dashboard. https://fis.fda.gov/sense/app/95239e26-e0be-42c9-a1e4-185269bfa989/surface/
• Jeevarethinam A, et al. Signal mining of botulinum toxin type A adverse events based on FAERS database. Front Hum Neurosci. 2025. https://www.frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1676051/full
• FDA. FAERS Public Dashboard for Cosmetic Products. https://www.fda.gov/tools/fda-adverse-event-reporting-system-faers-public-dashboard
• Data source: FDA Adverse Event Reporting System (FAERS) for aesthetic injectables; analysis by AestheticMedGuide, run date 2026-06-10. Analysis sample: 98,626 FAERS event records for aesthetic injectable brands, covering reports received 2004–2026.