ETIFOXINE: 324 Adverse Event Reports & Safety Profile
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324
Total FAERS Reports
58 (17.9%)
Deaths Reported
242
Hospitalizations
324
As Primary/Secondary Suspect
21
Life-Threatening
1
Disabilities
First Report: 201101 · Latest Report: 20250621
What Are the Most Common ETIFOXINE Side Effects?
#1 Most Reported
Toxicity to various agents
68 reports (21.0%)
#2 Most Reported
Somnolence
55 reports (17.0%)
#3 Most Reported
Hepatic cytolysis
50 reports (15.4%)
All ETIFOXINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Toxicity to various agents | 68 | 21.0% | 26 | 60 |
| Somnolence | 55 | 17.0% | 25 | 44 |
| Hepatic cytolysis | 50 | 15.4% | 32 | 33 |
| Coma | 32 | 9.9% | 20 | 26 |
| Drug abuse | 30 | 9.3% | 15 | 25 |
| Myocarditis | 28 | 8.6% | 25 | 17 |
| Hepatitis acute | 26 | 8.0% | 18 | 21 |
| Altered state of consciousness | 24 | 7.4% | 0 | 24 |
| Overdose | 24 | 7.4% | 20 | 19 |
| Confusional state | 23 | 7.1% | 19 | 17 |
| Cardiac disorder | 22 | 6.8% | 22 | 16 |
| Cardiomyopathy | 20 | 6.2% | 20 | 14 |
| Encephalopathy | 20 | 6.2% | 20 | 14 |
| Hyperglycaemia | 20 | 6.2% | 20 | 14 |
| Logorrhoea | 20 | 6.2% | 12 | 15 |
| Respiratory depression | 20 | 6.2% | 20 | 14 |
| Synovitis | 20 | 6.2% | 20 | 19 |
| Accidental poisoning | 19 | 5.9% | 19 | 14 |
| Coronary artery stenosis | 19 | 5.9% | 19 | 17 |
| Labelled drug-drug interaction issue | 19 | 5.9% | 19 | 14 |
Who Reports ETIFOXINE Side Effects? Age & Gender Data
Gender: 57.0% female, 43.0% male. Average age: 49.3 years. Most reports from: FR. View detailed demographics →
Is ETIFOXINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 0 |
| 2012 | 6 | 0 | 1 |
| 2014 | 13 | 0 | 13 |
| 2015 | 18 | 6 | 12 |
| 2016 | 45 | 28 | 36 |
| 2017 | 32 | 0 | 30 |
| 2018 | 45 | 0 | 43 |
| 2019 | 12 | 4 | 8 |
| 2020 | 31 | 0 | 30 |
| 2021 | 34 | 0 | 24 |
| 2022 | 7 | 0 | 7 |
| 2023 | 11 | 0 | 7 |
| 2024 | 14 | 0 | 6 |
| 2025 | 9 | 0 | 9 |
What Is ETIFOXINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 106 |
| Anxiety | 81 |
| Depression | 28 |
| Suicide attempt | 15 |
| Stress | 14 |
| Poisoning deliberate | 12 |
| Anxiety disorder | 8 |
| Mixed anxiety and depressive disorder | 7 |
| Bipolar disorder | 6 |
| Toxicity to various agents | 6 |
ETIFOXINE vs Alternatives: Which Is Safer?
ETIFOXINE vs ETIZOLAM
ETIFOXINE vs ETODOLAC
ETIFOXINE vs ETOMIDATE
ETIFOXINE vs ETONOGESTREL
ETIFOXINE vs ETOPOSIDE
ETIFOXINE vs ETORICOXIB
ETIFOXINE vs ETRASIMOD ARGININE
ETIFOXINE vs ETRAVIRINE
ETIFOXINE vs EUCALYPTOL\MENTHOL\METHYL SALICYLATE\THYMOL
ETIFOXINE vs EVEROLIMUS
Official FDA Label for ETIFOXINE
Official prescribing information from the FDA-approved drug label.