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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.

TOLEP: 32 Adverse Event Reports & Safety Profile

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32
Total FAERS Reports
0
Deaths Reported
23
Hospitalizations
32
As Primary/Secondary Suspect
1
Life-Threatening

First Report: 20130304 · Latest Report: 20140428

What Are the Most Common TOLEP Side Effects?

#1 Most Reported
Sopor
10 reports (31.3%)
#2 Most Reported
Overdose
7 reports (21.9%)
#3 Most Reported
Coma
6 reports (18.8%)

All TOLEP Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Sopor 10 31.3% 0 10
Overdose 7 21.9% 0 6
Coma 6 18.8% 0 6
Dysarthria 5 15.6% 0 5
Hyponatraemia 5 15.6% 0 1

Who Reports TOLEP Side Effects? Age & Gender Data

Average age: 59.2 years. Most reports from: IT. View detailed demographics →

Is TOLEP Getting Safer? Reports by Year

YearReportsDeathsHosp.
2013 20 0 13
2014 12 0 10

View full timeline →

What Is TOLEP Used For?

IndicationReports
Product used for unknown indication 13

Official FDA Label for TOLEP

Official prescribing information from the FDA-approved drug label.