PROMETRIUM: 35 Adverse Event Reports & Safety Profile
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35
Total FAERS Reports
1 (2.9%)
Deaths Reported
6
Hospitalizations
35
As Primary/Secondary Suspect
3
Disabilities
First Report: 19990403 · Latest Report: 20140421
What Are the Most Common PROMETRIUM Side Effects?
#1 Most Reported
Breast cancer female
6 reports (17.1%)
#2 Most Reported
Invasive ductal breast carcinoma
4 reports (11.4%)
#3 Most Reported
Vaginal haemorrhage
3 reports (8.6%)
All PROMETRIUM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Breast cancer female | 6 | 17.1% | 1 | 0 |
Who Reports PROMETRIUM Side Effects? Age & Gender Data
Average age: 51.3 years. Most reports from: US. View detailed demographics →
Is PROMETRIUM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 0 |
| 2001 | 2 | 0 | 0 |
| 2002 | 1 | 0 | 0 |
| 2003 | 7 | 0 | 1 |
| 2004 | 1 | 0 | 0 |
| 2005 | 2 | 1 | 0 |
| 2006 | 1 | 0 | 1 |
| 2007 | 1 | 0 | 1 |
| 2009 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 1 |
| 2012 | 1 | 0 | 0 |
| 2013 | 3 | 0 | 1 |
| 2014 | 3 | 0 | 1 |
What Is PROMETRIUM Used For?
| Indication | Reports |
|---|---|
| Hormone replacement therapy | 17 |
Official FDA Label for PROMETRIUM
Official prescribing information from the FDA-approved drug label.