PREMARIN: 679 Adverse Event Reports & Safety Profile
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679
Total FAERS Reports
20 (2.9%)
Deaths Reported
45
Hospitalizations
679
As Primary/Secondary Suspect
4
Life-Threatening
12
Disabilities
First Report: 1970 · Latest Report: 20140528
What Are the Most Common PREMARIN Side Effects?
#1 Most Reported
Breast cancer female
89 reports (13.1%)
#2 Most Reported
Drug ineffective
47 reports (6.9%)
#3 Most Reported
Invasive ductal breast carcinoma
41 reports (6.0%)
All PREMARIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Breast cancer female | 89 | 13.1% | 5 | 14 |
| Drug ineffective | 47 | 6.9% | 0 | 0 |
| Invasive ductal breast carcinoma | 41 | 6.0% | 1 | 2 |
| Hot flush | 37 | 5.5% | 0 | 1 |
| Malaise | 29 | 4.3% | 0 | 3 |
| Breast cancer | 26 | 3.8% | 3 | 1 |
| Drug effect incomplete | 23 | 3.4% | 0 | 0 |
| Headache | 22 | 3.2% | 0 | 2 |
| Product quality issue | 21 | 3.1% | 0 | 1 |
| Pain | 20 | 3.0% | 0 | 3 |
| Feeling abnormal | 19 | 2.8% | 0 | 0 |
| Drug hypersensitivity | 18 | 2.7% | 0 | 0 |
| Insomnia | 17 | 2.5% | 0 | 1 |
| Dizziness | 15 | 2.2% | 0 | 2 |
| Vulvovaginal discomfort | 15 | 2.2% | 0 | 0 |
| Depression | 14 | 2.1% | 1 | 3 |
| Vulvovaginal burning sensation | 13 | 1.9% | 0 | 0 |
| Vulvovaginal pain | 13 | 1.9% | 0 | 0 |
| Breast cancer metastatic | 12 | 1.8% | 3 | 3 |
| Hypertension | 12 | 1.8% | 0 | 0 |
Who Reports PREMARIN Side Effects? Age & Gender Data
Average age: 62.0 years. Most reports from: US. View detailed demographics →
Is PREMARIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 24 | 2 | 3 |
| 2001 | 31 | 1 | 4 |
| 2002 | 49 | 3 | 6 |
| 2003 | 29 | 0 | 4 |
| 2004 | 20 | 1 | 3 |
| 2005 | 4 | 1 | 1 |
| 2007 | 2 | 0 | 0 |
| 2008 | 4 | 0 | 0 |
| 2009 | 2 | 0 | 1 |
| 2010 | 6 | 0 | 2 |
| 2011 | 8 | 0 | 1 |
| 2012 | 12 | 0 | 1 |
| 2013 | 66 | 0 | 9 |
| 2014 | 64 | 0 | 3 |
What Is PREMARIN Used For?
| Indication | Reports |
|---|---|
| Hormone replacement therapy | 222 |
| Menopausal symptoms | 43 |
| Vulvovaginal dryness | 36 |
| Oestrogen replacement therapy | 26 |
| Hot flush | 17 |
| Atrophic vulvovaginitis | 16 |
| Dyspareunia | 8 |
| Menopause | 6 |
| Product used for unknown indication | 6 |
PREMARIN vs Alternatives: Which Is Safer?
PREMARIN vs PREMPRO
PREMARIN vs PRETOMANID
PREMARIN vs PREVISCAN
PREMARIN vs PREZISTA
PREMARIN vs PRILOCAINE
PREMARIN vs PRILOSEC
PREMARIN vs PRILOSEC OTC
PREMARIN vs PRIMAQUINE
PREMARIN vs PRIMIDONE
PREMARIN vs PRISTINAMYCIN
Official FDA Label for PREMARIN
Official prescribing information from the FDA-approved drug label.