DROMOSTANOLONE: 71 Adverse Event Reports & Safety Profile
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71
Total FAERS Reports
17 (23.9%)
Deaths Reported
48
Hospitalizations
71
As Primary/Secondary Suspect
16
Life-Threatening
2
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Active Ingredient: DROMOSTANOLONE PROPIONATE · FDA Application: 012936 ·
First Report: 19960314 · Latest Report: 20240101
What Are the Most Common DROMOSTANOLONE Side Effects?
#1 Most Reported
Drug abuse
31 reports (43.7%)
#2 Most Reported
Intentional product misuse
16 reports (22.5%)
#3 Most Reported
Secondary hypogonadism
10 reports (14.1%)
All DROMOSTANOLONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug abuse | 31 | 43.7% | 14 | 23 |
| Intentional product misuse | 16 | 22.5% | 10 | 13 |
| Secondary hypogonadism | 10 | 14.1% | 0 | 10 |
| Autoimmune thyroiditis | 9 | 12.7% | 0 | 9 |
| Diabetes mellitus | 9 | 12.7% | 0 | 9 |
| Multiple organ dysfunction syndrome | 9 | 12.7% | 9 | 8 |
| Hepatic neoplasm | 8 | 11.3% | 8 | 8 |
| Poisoning | 8 | 11.3% | 8 | 7 |
| Haematocrit increased | 7 | 9.9% | 0 | 7 |
| Intra-abdominal haemorrhage | 7 | 9.9% | 7 | 7 |
| Nephropathy | 7 | 9.9% | 0 | 7 |
| Off label use | 7 | 9.9% | 0 | 7 |
| Performance enhancing product use | 7 | 9.9% | 0 | 7 |
| Product use in unapproved indication | 7 | 9.9% | 0 | 5 |
| Acute kidney injury | 6 | 8.5% | 0 | 6 |
| Blood glucose increased | 6 | 8.5% | 0 | 6 |
| Glucose tolerance decreased | 6 | 8.5% | 0 | 6 |
| Hyperbilirubinaemia | 6 | 8.5% | 0 | 6 |
| Product use issue | 6 | 8.5% | 0 | 6 |
| Toxicity to various agents | 6 | 8.5% | 6 | 2 |
Who Reports DROMOSTANOLONE Side Effects? Age & Gender Data
Gender: 11.3% female, 88.7% male. Average age: 31.8 years. Most reports from: PT. View detailed demographics →
Is DROMOSTANOLONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 1 |
| 2017 | 2 | 0 | 2 |
| 2024 | 1 | 0 | 0 |
What Is DROMOSTANOLONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 28 |
| Muscle building therapy | 10 |
| Intentional product misuse | 6 |
| Performance enhancing product use | 6 |
Official FDA Label for DROMOSTANOLONE
Official prescribing information from the FDA-approved drug label.