OXYMETHOLONE: 56 Adverse Event Reports & Safety Profile
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56
Total FAERS Reports
5 (8.9%)
Deaths Reported
22
Hospitalizations
56
As Primary/Secondary Suspect
1
Life-Threatening
3
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
FDA Application: 016848 ·
First Report: 2012 · Latest Report: 20240929
What Are the Most Common OXYMETHOLONE Side Effects?
#1 Most Reported
Drug abuse
17 reports (30.4%)
#2 Most Reported
Aortic aneurysm
8 reports (14.3%)
#3 Most Reported
Polycythaemia
7 reports (12.5%)
All OXYMETHOLONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug abuse | 17 | 30.4% | 0 | 9 |
| Aortic aneurysm | 8 | 14.3% | 0 | 0 |
| Polycythaemia | 7 | 12.5% | 0 | 7 |
| Deafness neurosensory | 6 | 10.7% | 0 | 6 |
| Sepsis | 5 | 8.9% | 4 | 1 |
Who Reports OXYMETHOLONE Side Effects? Age & Gender Data
Gender: 11.4% female, 88.6% male. Average age: 26.8 years. Most reports from: US. View detailed demographics →
Is OXYMETHOLONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 2 | 0 | 1 |
| 2014 | 1 | 0 | 0 |
| 2015 | 2 | 0 | 1 |
| 2016 | 1 | 0 | 0 |
| 2019 | 3 | 0 | 3 |
| 2024 | 1 | 0 | 1 |
What Is OXYMETHOLONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 16 |
| Muscle building therapy | 8 |
| Congenital aplastic anaemia | 7 |
| Aplastic anaemia | 6 |
Official FDA Label for OXYMETHOLONE
Official prescribing information from the FDA-approved drug label.