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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.

VALBENAZINE DITOSYLATE: 613 Adverse Event Reports & Safety Profile

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613
Total FAERS Reports
27 (4.4%)
Deaths Reported
71
Hospitalizations
613
As Primary/Secondary Suspect
4
Life-Threatening
2
Disabilities

First Report: 20170801 · Latest Report: 20250918

What Are the Most Common VALBENAZINE DITOSYLATE Side Effects?

#1 Most Reported
Drug ineffective
56 reports (9.1%)
#2 Most Reported
Somnolence
53 reports (8.6%)
#3 Most Reported
Tremor
51 reports (8.3%)

All VALBENAZINE DITOSYLATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 56 9.1% 0 1
Somnolence 53 8.7% 0 4
Tremor 51 8.3% 0 11
Drooling 42 6.9% 0 4
Parkinsonism 40 6.5% 0 6
Tardive dyskinesia 38 6.2% 0 8
Fatigue 30 4.9% 0 3
Dyskinesia 29 4.7% 1 5
Fall 27 4.4% 1 12
Dizziness 26 4.2% 0 3
Therapeutic product effect decreased 26 4.2% 0 2
Death 20 3.3% 20 1
Depression 20 3.3% 0 5
Sedation 20 3.3% 0 2
Anxiety 19 3.1% 0 5
Hospitalisation 19 3.1% 0 19
Nausea 19 3.1% 0 1
Rash 18 2.9% 0 0
Off label use 17 2.8% 0 4
Insomnia 16 2.6% 0 2

Who Reports VALBENAZINE DITOSYLATE Side Effects? Age & Gender Data

Gender: 66.3% female, 33.7% male. Average age: 59.7 years. Most reports from: US. View detailed demographics →

Is VALBENAZINE DITOSYLATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2017 2 0 2
2018 1 0 1
2020 1 0 0
2021 2 0 0
2023 6 0 2
2024 13 2 4
2025 104 10 24

View full timeline →

What Is VALBENAZINE DITOSYLATE Used For?

IndicationReports
Tardive dyskinesia 491
Product used for unknown indication 72
Huntington's disease 19
Dyskinesia 11

VALBENAZINE DITOSYLATE vs Alternatives: Which Is Safer?

VALBENAZINE DITOSYLATE vs VALDECOXIB VALBENAZINE DITOSYLATE vs VALERIAN VALBENAZINE DITOSYLATE vs VALGANCICLOVIR VALBENAZINE DITOSYLATE vs VALIUM VALBENAZINE DITOSYLATE vs VALPROATE VALBENAZINE DITOSYLATE vs VALPROIC ACID VALBENAZINE DITOSYLATE vs VALPROMIDE VALBENAZINE DITOSYLATE vs VALSARTAN VALBENAZINE DITOSYLATE vs VALTREX VALBENAZINE DITOSYLATE vs VAMOROLONE

Official FDA Label for VALBENAZINE DITOSYLATE

Official prescribing information from the FDA-approved drug label.