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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.

TROSPIUM\XANOMELINE: 1,108 Adverse Event Reports & Safety Profile

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1,108
Total FAERS Reports
18 (1.6%)
Deaths Reported
75
Hospitalizations
1,108
As Primary/Secondary Suspect
10
Life-Threatening
3
Disabilities

Active Ingredient: TROSPIUM CHLORIDE\XANOMELINE ·

First Report: 20230301 · Latest Report: 20250921

What Are the Most Common TROSPIUM\XANOMELINE Side Effects?

#1 Most Reported
Nausea
245 reports (22.1%)
#2 Most Reported
Vomiting
196 reports (17.7%)
#3 Most Reported
Constipation
86 reports (7.8%)

All TROSPIUM\XANOMELINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Nausea 245 22.1% 0 12
Vomiting 196 17.7% 0 12
Constipation 86 7.8% 1 6
Off label use 77 7.0% 1 5
Urinary retention 72 6.5% 0 6
Dizziness 46 4.2% 0 4
Vision blurred 40 3.6% 0 1
Hyperhidrosis 39 3.5% 0 1
Dyspepsia 36 3.3% 0 0
Gastrooesophageal reflux disease 32 2.9% 0 1
Drug ineffective 29 2.6% 0 2
Somnolence 28 2.5% 0 1
Treatment noncompliance 27 2.4% 0 1
Diarrhoea 26 2.4% 0 2
Dry mouth 26 2.4% 0 2
Abdominal pain upper 25 2.3% 0 0
Drooling 25 2.3% 0 1
Psychotic disorder 24 2.2% 0 11
Abdominal discomfort 23 2.1% 0 4
Heart rate increased 21 1.9% 0 1

Who Reports TROSPIUM\XANOMELINE Side Effects? Age & Gender Data

Gender: 43.0% female, 57.0% male. Average age: 41.5 years. Most reports from: US. View detailed demographics →

Is TROSPIUM\XANOMELINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2023 1 0 0
2024 118 0 4
2025 371 10 30

View full timeline →

What Is TROSPIUM\XANOMELINE Used For?

IndicationReports
Schizophrenia 627
Product used for unknown indication 412
Schizoaffective disorder 27
Psychotic disorder 11
Bipolar disorder 6

TROSPIUM\XANOMELINE vs Alternatives: Which Is Safer?

TROSPIUM\XANOMELINE vs TRUVADA TROSPIUM\XANOMELINE vs TRYPTOPHAN TROSPIUM\XANOMELINE vs TUBERCULIN PURIFIED PROTEIN DERIVATIVE TROSPIUM\XANOMELINE vs TUCATINIB TROSPIUM\XANOMELINE vs TUCIDINOSTAT TROSPIUM\XANOMELINE vs TYKERB TROSPIUM\XANOMELINE vs TYLENOL TROSPIUM\XANOMELINE vs TYROTHRICIN TROSPIUM\XANOMELINE vs TYSABRI TROSPIUM\XANOMELINE vs TYVASO

Official FDA Label for TROSPIUM\XANOMELINE

Official prescribing information from the FDA-approved drug label.