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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.

IDEBENONE: 52 Adverse Event Reports & Safety Profile

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52
Total FAERS Reports
7 (13.5%)
Deaths Reported
30
Hospitalizations
52
As Primary/Secondary Suspect
3
Life-Threatening

First Report: 201101 · Latest Report: 20231108

What Are the Most Common IDEBENONE Side Effects?

#1 Most Reported
Cholestasis
14 reports (26.9%)
#2 Most Reported
Fatigue
12 reports (23.1%)
#3 Most Reported
Thrombocytopenia
10 reports (19.2%)

All IDEBENONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Cholestasis 14 26.9% 2 14
Fatigue 12 23.1% 2 8
Thrombocytopenia 10 19.2% 2 10
Activated partial thromboplastin time prolonged 9 17.3% 2 9
Cataract nuclear 9 17.3% 0 1
Hepatic encephalopathy 9 17.3% 2 9
Vomiting 9 17.3% 3 9
Decreased appetite 8 15.4% 2 8
Hepatitis acute 8 15.4% 2 8
Jaundice 8 15.4% 2 8
Abdominal pain 5 9.6% 2 5
Drug-induced liver injury 5 9.6% 2 4
Product use in unapproved indication 5 9.6% 1 0
Renal tubular disorder 5 9.6% 0 5

Who Reports IDEBENONE Side Effects? Age & Gender Data

Gender: 47.3% female, 52.7% male. Average age: 46.1 years. Most reports from: CN. View detailed demographics →

Is IDEBENONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 4 0 0
2014 2 2 1
2015 1 0 0
2018 6 0 6
2019 2 0 1
2020 4 0 4
2021 7 0 6
2022 2 2 0
2023 1 0 1

View full timeline →

What Is IDEBENONE Used For?

IndicationReports
Product used for unknown indication 14
Mitochondrial encephalomyopathy 11
Friedreich's ataxia 10

Official FDA Label for IDEBENONE

Official prescribing information from the FDA-approved drug label.