FLUOXYMESTERONE: 31 Adverse Event Reports & Safety Profile
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31
Total FAERS Reports
11 (35.5%)
Deaths Reported
23
Hospitalizations
31
As Primary/Secondary Suspect
8
Life-Threatening
1
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available
FDA Application: 010611 ·
First Report: 19960314 · Latest Report: 201804
What Are the Most Common FLUOXYMESTERONE Side Effects?
#1 Most Reported
Drug abuse
16 reports (51.6%)
#2 Most Reported
Intentional product misuse
13 reports (41.9%)
#3 Most Reported
Secondary hypogonadism
9 reports (29.0%)
All FLUOXYMESTERONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug abuse | 16 | 51.6% | 7 | 15 |
| Intentional product misuse | 13 | 41.9% | 9 | 11 |
| Autoimmune thyroiditis | 9 | 29.0% | 0 | 9 |
| Diabetes mellitus | 9 | 29.0% | 0 | 9 |
| Secondary hypogonadism | 9 | 29.0% | 0 | 9 |
| Hepatic neoplasm | 8 | 25.8% | 8 | 8 |
| Multiple organ dysfunction syndrome | 8 | 25.8% | 8 | 8 |
| Haematocrit increased | 7 | 22.6% | 0 | 7 |
| Intra-abdominal haemorrhage | 7 | 22.6% | 7 | 7 |
| Performance enhancing product use | 7 | 22.6% | 0 | 7 |
| Poisoning | 7 | 22.6% | 7 | 7 |
| Blood glucose increased | 6 | 19.4% | 0 | 6 |
| Glucose tolerance decreased | 6 | 19.4% | 0 | 6 |
| Product use in unapproved indication | 6 | 19.4% | 0 | 5 |
| Off label use | 5 | 16.1% | 0 | 5 |
| Product use issue | 5 | 16.1% | 0 | 5 |
Who Reports FLUOXYMESTERONE Side Effects? Age & Gender Data
Gender: 19.4% female, 80.6% male. Average age: 33.0 years. Most reports from: PT. View detailed demographics →
Is FLUOXYMESTERONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 0 |
| 2016 | 1 | 0 | 0 |
| 2017 | 1 | 1 | 0 |
| 2018 | 1 | 1 | 0 |
What Is FLUOXYMESTERONE Used For?
| Indication | Reports |
|---|---|
| Intentional product misuse | 6 |
| Muscle building therapy | 5 |
| Performance enhancing product use | 5 |
| Product used for unknown indication | 5 |
Official FDA Label for FLUOXYMESTERONE
Official prescribing information from the FDA-approved drug label.