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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

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

YearReportsDeathsHosp.
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

View full timeline →

What Is PREMARIN Used For?

IndicationReports
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.