OXANDROLONE: 91 Adverse Event Reports & Safety Profile
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91
Total FAERS Reports
21 (23.1%)
Deaths Reported
49
Hospitalizations
91
As Primary/Secondary Suspect
13
Life-Threatening
2
Disabilities
Dec 1, 2006
FDA Approved
Discontinued
Status
Yes
Generic Available
FDA Application: 076761 ·
First Report: 2006 · Latest Report: 20230801
What Are the Most Common OXANDROLONE Side Effects?
#1 Most Reported
Drug abuse
27 reports (29.7%)
#2 Most Reported
Drug-induced liver injury
16 reports (17.6%)
#3 Most Reported
Testicular atrophy
12 reports (13.2%)
All OXANDROLONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug abuse | 27 | 29.7% | 15 | 11 |
| Drug-induced liver injury | 16 | 17.6% | 0 | 12 |
| Off label use | 12 | 13.2% | 1 | 10 |
| Testicular atrophy | 12 | 13.2% | 10 | 1 |
| Toxicity to various agents | 11 | 12.1% | 11 | 0 |
| Myocardial fibrosis | 10 | 11.0% | 9 | 1 |
| Cardiac death | 9 | 9.9% | 9 | 0 |
| Cardiotoxicity | 9 | 9.9% | 9 | 0 |
| Left ventricular hypertrophy | 9 | 9.9% | 9 | 0 |
| Muscle mass | 9 | 9.9% | 9 | 0 |
| Polycythaemia | 9 | 9.9% | 4 | 9 |
| Cholestasis | 8 | 8.8% | 0 | 4 |
| Prescription drug used without a prescription | 8 | 8.8% | 7 | 1 |
| Acute hepatic failure | 7 | 7.7% | 2 | 5 |
| Acute kidney injury | 5 | 5.5% | 0 | 4 |
| Cerebral haemorrhage | 5 | 5.5% | 0 | 5 |
| Intentional product misuse | 5 | 5.5% | 0 | 4 |
| Rhabdomyolysis | 5 | 5.5% | 1 | 5 |
Who Reports OXANDROLONE Side Effects? Age & Gender Data
Gender: 12.0% female, 88.0% male. Average age: 38.3 years. Most reports from: US. View detailed demographics →
Is OXANDROLONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 1 | 0 | 1 |
| 2011 | 1 | 0 | 1 |
| 2014 | 2 | 0 | 1 |
| 2015 | 1 | 0 | 0 |
| 2016 | 1 | 0 | 0 |
| 2017 | 2 | 0 | 2 |
| 2018 | 1 | 0 | 0 |
| 2019 | 6 | 0 | 3 |
| 2021 | 1 | 0 | 0 |
| 2023 | 5 | 4 | 5 |
What Is OXANDROLONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 36 |
| Muscle building therapy | 13 |
| Performance enhancing product use | 6 |
| Drug abuse | 5 |
Official FDA Label for OXANDROLONE
Official prescribing information from the FDA-approved drug label.