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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

PRABOTULINUMTOXINA-XVFS: 3,249 Adverse Event Reports & Safety Profile

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3,249
Total FAERS Reports
1
Deaths Reported
19
Hospitalizations
3,249
As Primary/Secondary Suspect
3
Life-Threatening
7
Disabilities
Prescription
Status

FDA Application: 761085 ·

First Report: 20180718 · Latest Report: 20250709

What Are the Most Common PRABOTULINUMTOXINA-XVFS Side Effects?

#1 Most Reported
Drug ineffective
1,332 reports (41.0%)
#2 Most Reported
Off label use
1,088 reports (33.5%)
#3 Most Reported
Therapeutic product effect decreased
714 reports (22.0%)

All PRABOTULINUMTOXINA-XVFS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 1,332 41.0% 0 2
Off label use 1,088 33.5% 1 5
Therapeutic product effect decreased 714 22.0% 0 0
Drug effect less than expected 354 10.9% 0 0
Headache 153 4.7% 0 6
Injection site pain 99 3.1% 0 0
Patient dissatisfaction with treatment 90 2.8% 0 0
Injection site swelling 89 2.7% 0 0
Inappropriate schedule of product administration 72 2.2% 0 0
Injection site erythema 62 1.9% 0 0
Eyelid ptosis 61 1.9% 0 0
Product preparation issue 56 1.7% 0 0
Injection site pruritus 45 1.4% 0 0
Product storage error 39 1.2% 0 0
Dizziness 33 1.0% 0 3
Vision blurred 31 1.0% 0 4
Injection site papule 27 0.8% 0 0
Vertigo 21 0.7% 0 0
Therapeutic product effect incomplete 19 0.6% 0 0
Pain 18 0.6% 0 0

Who Reports PRABOTULINUMTOXINA-XVFS Side Effects? Age & Gender Data

Gender: 90.7% female, 9.3% male. Average age: 46.2 years. Most reports from: US. View detailed demographics →

Is PRABOTULINUMTOXINA-XVFS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2018 1 0 0
2019 357 0 8
2020 76 0 1
2021 85 0 1
2022 116 0 0
2023 110 1 0
2024 81 0 4
2025 11 0 4

View full timeline →

What Is PRABOTULINUMTOXINA-XVFS Used For?

IndicationReports
Product used for unknown indication 2,750
Skin wrinkling 1,045
Product use in unapproved indication 152
Off label use 18
Face lift 8
Skin cosmetic procedure 5

PRABOTULINUMTOXINA-XVFS vs Alternatives: Which Is Safer?

PRABOTULINUMTOXINA-XVFS vs PRADAXA PRABOTULINUMTOXINA-XVFS vs PRALATREXATE PRABOTULINUMTOXINA-XVFS vs PRALSETINIB PRABOTULINUMTOXINA-XVFS vs PRAMIPEXOLE PRABOTULINUMTOXINA-XVFS vs PRAMIPEXOLE\PRAMIPEXOLE PRABOTULINUMTOXINA-XVFS vs PRAMLINTIDE PRABOTULINUMTOXINA-XVFS vs PRASTERONE PRABOTULINUMTOXINA-XVFS vs PRASUGREL PRABOTULINUMTOXINA-XVFS vs PRAVASTATIN PRABOTULINUMTOXINA-XVFS vs PRAVASTATIN\PRAVASTATIN

Official FDA Label for PRABOTULINUMTOXINA-XVFS

Official prescribing information from the FDA-approved drug label.