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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.

BOTULINUM TOXIN NOS: 272 Adverse Event Reports & Safety Profile

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272
Total FAERS Reports
19 (7.0%)
Deaths Reported
87
Hospitalizations
272
As Primary/Secondary Suspect
22
Life-Threatening
23
Disabilities

First Report: 20070901 · Latest Report: 20250122

What Are the Most Common BOTULINUM TOXIN NOS Side Effects?

#1 Most Reported
Drug ineffective
99 reports (36.4%)
#2 Most Reported
Off label use
75 reports (27.6%)
#3 Most Reported
Product use in unapproved indication
44 reports (16.2%)

All BOTULINUM TOXIN NOS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 99 36.4% 10 23
Off label use 75 27.6% 11 24
Product use in unapproved indication 44 16.2% 7 9
Migraine 40 14.7% 5 13
Treatment failure 39 14.3% 8 10
Headache 33 12.1% 7 11
Nausea 32 11.8% 9 10
Sedation 29 10.7% 0 0
Drug intolerance 28 10.3% 6 7
Pain 26 9.6% 9 14
Fatigue 23 8.5% 9 11
Nephrolithiasis 22 8.1% 0 0
Paraesthesia 22 8.1% 3 10
Hyperhidrosis 21 7.7% 0 0
Nightmare 21 7.7% 0 0
Drug ineffective for unapproved indication 20 7.4% 0 6
Condition aggravated 19 7.0% 10 14
Botulism 18 6.6% 0 15
Maternal exposure during pregnancy 14 5.2% 11 11
Asthenia 13 4.8% 8 12

Who Reports BOTULINUM TOXIN NOS Side Effects? Age & Gender Data

Gender: 48.5% female, 51.5% male. Average age: 41.7 years. Most reports from: US. View detailed demographics →

Is BOTULINUM TOXIN NOS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 1 0 1
2015 2 0 2
2017 2 0 2
2018 4 0 3
2020 2 0 0
2022 3 0 1
2023 4 0 0
2024 8 0 6
2025 2 0 0

View full timeline →

What Is BOTULINUM TOXIN NOS Used For?

IndicationReports
Product used for unknown indication 79
Migraine 38
Dystonia 19
Muscle spasticity 13
Chronic cutaneous lupus erythematosus 10
Migraine prophylaxis 8
Skin ulcer 7
Epilepsy 6
Tardive dyskinesia 6
Bruxism 5

BOTULINUM TOXIN NOS vs Alternatives: Which Is Safer?

BOTULINUM TOXIN NOS vs BOTULINUM TOXIN TYPE A BOTULINUM TOXIN NOS vs BREMELANOTIDE BOTULINUM TOXIN NOS vs BRENTUXIMAB BOTULINUM TOXIN NOS vs BRENTUXIMAB VEDOTIN BOTULINUM TOXIN NOS vs BREO ELLIPTA BOTULINUM TOXIN NOS vs BREXANOLONE BOTULINUM TOXIN NOS vs BREXPIPRAZOLE BOTULINUM TOXIN NOS vs BREXUCABTAGENE AUTOLEUCEL BOTULINUM TOXIN NOS vs BRIGATINIB BOTULINUM TOXIN NOS vs BRILINTA

Official FDA Label for BOTULINUM TOXIN NOS

Official prescribing information from the FDA-approved drug label.