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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.

ESTRADIOL\PROGESTERONE: 464 Adverse Event Reports & Safety Profile

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464
Total FAERS Reports
2 (0.4%)
Deaths Reported
14
Hospitalizations
464
As Primary/Secondary Suspect
3
Life-Threatening
4
Disabilities

First Report: 200509 · Latest Report: 20241001

What Are the Most Common ESTRADIOL\PROGESTERONE Side Effects?

#1 Most Reported
Off label use
61 reports (13.1%)
#2 Most Reported
Drug ineffective
57 reports (12.3%)
#3 Most Reported
Vaginal haemorrhage
52 reports (11.2%)

All ESTRADIOL\PROGESTERONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 61 13.2% 0 2
Drug ineffective 57 12.3% 0 0
Headache 52 11.2% 0 1
Vaginal haemorrhage 52 11.2% 0 0
Hot flush 38 8.2% 0 1
Dizziness 37 8.0% 0 2
Breast tenderness 36 7.8% 0 0
Nausea 30 6.5% 0 0
Weight increased 23 5.0% 0 0
Fatigue 18 3.9% 0 0
Muscle spasms 17 3.7% 0 0
Feeling abnormal 14 3.0% 0 0
Product dose omission issue 14 3.0% 0 0
Abdominal distension 13 2.8% 0 0
Diarrhoea 13 2.8% 0 0
Somnolence 13 2.8% 0 0
Insomnia 12 2.6% 0 0
Middle insomnia 11 2.4% 0 0
Malaise 10 2.2% 0 0
Pain in extremity 10 2.2% 0 0

Who Reports ESTRADIOL\PROGESTERONE Side Effects? Age & Gender Data

Gender: 100.0% female, 0.0% male. Average age: 55.5 years. Most reports from: US. View detailed demographics →

Is ESTRADIOL\PROGESTERONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 1
2013 1 0 1
2014 1 0 0
2015 3 0 1
2018 1 0 1
2019 161 0 4
2020 87 1 0
2021 26 0 1
2022 12 0 0
2023 6 0 1
2024 8 1 2

View full timeline →

What Is ESTRADIOL\PROGESTERONE Used For?

IndicationReports
Hot flush 105
Menopause 36
Hormone replacement therapy 34
Menopausal symptoms 33
Night sweats 21
Product used for unknown indication 19
Insomnia 14
Vulvovaginal dryness 7
Hormone level abnormal 5
Ill-defined disorder 5

ESTRADIOL\PROGESTERONE vs Alternatives: Which Is Safer?

ESTRADIOL\PROGESTERONE vs ESTRAMUSTINE ESTRADIOL\PROGESTERONE vs ESTRING ESTRADIOL\PROGESTERONE vs ESTRIOL ESTRADIOL\PROGESTERONE vs ESTROGENS ESTRADIOL\PROGESTERONE vs ESTROGENS, CONJUGATED ESTRADIOL\PROGESTERONE vs ESTROGENS, CONJUGATED\MEDROXYPROGESTERONE ESTRADIOL\PROGESTERONE vs ESTROGENS, ESTERIFIED ESTRADIOL\PROGESTERONE vs ESZOPICLONE ESTRADIOL\PROGESTERONE vs ETANERCEPT ESTRADIOL\PROGESTERONE vs ETANERCEPT-SZZS

Official FDA Label for ESTRADIOL\PROGESTERONE

Official prescribing information from the FDA-approved drug label.