TEPRENONE: 98 Adverse Event Reports & Safety Profile
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98
Total FAERS Reports
14 (14.3%)
Deaths Reported
47
Hospitalizations
98
As Primary/Secondary Suspect
13
Life-Threatening
4
Disabilities
First Report: 20020203 · Latest Report: 20250523
What Are the Most Common TEPRENONE Side Effects?
#1 Most Reported
Rash
6 reports (6.1%)
#2 Most Reported
Drug-induced liver injury
6 reports (6.1%)
#3 Most Reported
Drug eruption
6 reports (6.1%)
All TEPRENONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Constipation | 6 | 6.1% | 0 | 4 |
| Drug eruption | 6 | 6.1% | 0 | 4 |
| Drug-induced liver injury | 6 | 6.1% | 0 | 3 |
| Rash | 6 | 6.1% | 0 | 3 |
| Decreased appetite | 5 | 5.1% | 1 | 3 |
| Sepsis | 5 | 5.1% | 2 | 1 |
Who Reports TEPRENONE Side Effects? Age & Gender Data
Gender: 52.1% female, 47.9% male. Average age: 64.8 years. Most reports from: JP. View detailed demographics →
Is TEPRENONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2002 | 1 | 0 | 1 |
| 2003 | 1 | 0 | 1 |
| 2009 | 1 | 0 | 1 |
| 2010 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2012 | 3 | 0 | 2 |
| 2013 | 2 | 1 | 1 |
| 2014 | 8 | 1 | 6 |
| 2015 | 8 | 1 | 5 |
| 2016 | 7 | 3 | 6 |
| 2017 | 4 | 1 | 1 |
| 2018 | 3 | 1 | 1 |
| 2019 | 6 | 1 | 2 |
| 2020 | 1 | 0 | 1 |
| 2021 | 2 | 0 | 2 |
| 2022 | 4 | 0 | 1 |
| 2023 | 4 | 0 | 1 |
| 2024 | 8 | 0 | 1 |
| 2025 | 3 | 1 | 2 |
What Is TEPRENONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 25 |
| Gastritis | 11 |
| Prophylaxis against gastrointestinal ulcer | 6 |
| Prophylaxis | 5 |
Official FDA Label for TEPRENONE
Official prescribing information from the FDA-approved drug label.