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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.

PROVERA: 185 Adverse Event Reports & Safety Profile

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185
Total FAERS Reports
10 (5.4%)
Deaths Reported
20
Hospitalizations
185
As Primary/Secondary Suspect
1
Life-Threatening
7
Disabilities

First Report: 19920225 · Latest Report: 20140620

What Are the Most Common PROVERA Side Effects?

#1 Most Reported
Breast cancer female
89 reports (48.1%)
#2 Most Reported
Invasive ductal breast carcinoma
35 reports (18.9%)
#3 Most Reported
Breast cancer
18 reports (9.7%)

All PROVERA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Breast cancer female 89 48.1% 3 12
Invasive ductal breast carcinoma 35 18.9% 2 2
Breast cancer 18 9.7% 0 0
Breast cancer metastatic 12 6.5% 3 3
Depression 7 3.8% 1 3
Invasive lobular breast carcinoma 7 3.8% 0 1
Anxiety 5 2.7% 1 2

Who Reports PROVERA Side Effects? Age & Gender Data

Average age: 57.0 years. Most reports from: US. View detailed demographics →

Is PROVERA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 24 2 2
2001 30 1 4
2002 49 3 4
2003 23 0 4
2004 15 2 1
2005 3 0 1
2007 2 1 0
2010 1 0 1
2011 1 0 0
2012 2 0 0
2013 2 0 1
2014 4 0 1

View full timeline →

What Is PROVERA Used For?

IndicationReports
Hormone replacement therapy 161
Menopausal symptoms 6

PROVERA vs Alternatives: Which Is Safer?

PROVERA vs PROZAC PROVERA vs PRUCALOPRIDE PROVERA vs PSEUDOEPHEDRINE PROVERA vs PSEUDOEPHEDRINE\TRIPROLIDINE PROVERA vs PSYLLIUM HUSK PROVERA vs PULMICORT FLEXHALER PROVERA vs PYRAZINAMIDE PROVERA vs PYRIDOSTIGMINE PROVERA vs PYRIDOXINE PROVERA vs PYRIDOXINE\THIAMINE

Official FDA Label for PROVERA

Official prescribing information from the FDA-approved drug label.