ETHIONAMIDE: 657 Adverse Event Reports & Safety Profile
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657
Total FAERS Reports
156 (23.7%)
Deaths Reported
225
Hospitalizations
657
As Primary/Secondary Suspect
48
Life-Threatening
31
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
FDA Application: 013026 ·
First Report: 20010206 · Latest Report: 20250410
What Are the Most Common ETHIONAMIDE Side Effects?
#1 Most Reported
Drug resistance
107 reports (16.3%)
#2 Most Reported
Vomiting
91 reports (13.9%)
#3 Most Reported
Anaemia
82 reports (12.5%)
All ETHIONAMIDE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug resistance | 107 | 16.3% | 6 | 30 |
| Vomiting | 91 | 13.9% | 18 | 40 |
| Anaemia | 82 | 12.5% | 13 | 33 |
| Nausea | 80 | 12.2% | 8 | 35 |
| Off label use | 68 | 10.4% | 16 | 29 |
| Electrocardiogram qt prolonged | 65 | 9.9% | 16 | 21 |
| Neuropathy peripheral | 52 | 7.9% | 13 | 15 |
| Tuberculosis | 49 | 7.5% | 16 | 15 |
| Treatment failure | 45 | 6.9% | 17 | 4 |
| Diarrhoea | 38 | 5.8% | 11 | 25 |
| Drug ineffective | 38 | 5.8% | 4 | 20 |
| Decreased appetite | 37 | 5.6% | 6 | 23 |
| Dyspnoea | 35 | 5.3% | 24 | 23 |
| Arthralgia | 32 | 4.9% | 8 | 16 |
| Drug reaction with eosinophilia and systemic symptoms | 28 | 4.3% | 3 | 16 |
| Pathogen resistance | 28 | 4.3% | 2 | 18 |
| Drug-induced liver injury | 26 | 4.0% | 3 | 16 |
| Psychotic disorder | 26 | 4.0% | 5 | 8 |
| Asthenia | 25 | 3.8% | 10 | 20 |
| Intentional product use issue | 24 | 3.7% | 11 | 12 |
Who Reports ETHIONAMIDE Side Effects? Age & Gender Data
Gender: 45.9% female, 54.1% male. Average age: 33.5 years. Most reports from: ZA. View detailed demographics →
Is ETHIONAMIDE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 0 |
| 2005 | 4 | 0 | 0 |
| 2006 | 1 | 0 | 0 |
| 2008 | 1 | 1 | 1 |
| 2009 | 2 | 0 | 0 |
| 2010 | 2 | 0 | 1 |
| 2011 | 5 | 0 | 4 |
| 2012 | 3 | 0 | 2 |
| 2013 | 3 | 2 | 3 |
| 2014 | 3 | 0 | 0 |
| 2015 | 11 | 1 | 2 |
| 2016 | 19 | 10 | 7 |
| 2017 | 65 | 24 | 31 |
| 2018 | 167 | 52 | 70 |
| 2019 | 39 | 13 | 17 |
| 2020 | 9 | 2 | 2 |
| 2021 | 4 | 0 | 3 |
| 2022 | 11 | 1 | 3 |
| 2023 | 6 | 1 | 2 |
| 2024 | 4 | 1 | 1 |
| 2025 | 1 | 0 | 0 |
What Is ETHIONAMIDE Used For?
| Indication | Reports |
|---|---|
| Tuberculosis | 486 |
| Pulmonary tuberculosis | 99 |
| Product used for unknown indication | 24 |
| Meningitis tuberculous | 10 |
| Disseminated tuberculosis | 7 |
| Extrapulmonary tuberculosis | 7 |
| Antibiotic prophylaxis | 6 |
ETHIONAMIDE vs Alternatives: Which Is Safer?
ETHIONAMIDE vs ETHOSUXIMIDE
ETHIONAMIDE vs ETHYL ICOSAPENTATE
ETHIONAMIDE vs ETHYL LOFLAZEPATE
ETHIONAMIDE vs ETHYLENE GLYCOL
ETHIONAMIDE vs ETIFOXINE
ETHIONAMIDE vs ETIZOLAM
ETHIONAMIDE vs ETODOLAC
ETHIONAMIDE vs ETOMIDATE
ETHIONAMIDE vs ETONOGESTREL
ETHIONAMIDE vs ETOPOSIDE
Official FDA Label for ETHIONAMIDE
Official prescribing information from the FDA-approved drug label.