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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.

BETANIS: 27 Adverse Event Reports & Safety Profile

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27
Total FAERS Reports
1 (3.7%)
Deaths Reported
13
Hospitalizations
27
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities

First Report: 20130427 · Latest Report: 20140521

What Are the Most Common BETANIS Side Effects?

#1 Most Reported
Loss of consciousness
5 reports (18.5%)
#2 Most Reported
Transient ischaemic attack
4 reports (14.8%)
#3 Most Reported
Off label use
3 reports (11.1%)

All BETANIS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Loss of consciousness 5 18.5% 0 5

Who Reports BETANIS Side Effects? Age & Gender Data

Average age: 76.0 years. Most reports from: JP. View detailed demographics →

Is BETANIS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2013 4 1 2
2014 13 0 8

View full timeline →

What Is BETANIS Used For?

IndicationReports
Hypertonic bladder 12
Product used for unknown indication 8

Official FDA Label for BETANIS

Official prescribing information from the FDA-approved drug label.