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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.

DIENOGEST\ESTRADIOL: 639 Adverse Event Reports & Safety Profile

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639
Total FAERS Reports
6 (0.9%)
Deaths Reported
143
Hospitalizations
639
As Primary/Secondary Suspect
22
Life-Threatening
21
Disabilities

Active Ingredient: DIENOGEST\ESTRADIOL VALERATE ·

First Report: 1999 · Latest Report: 20250821

What Are the Most Common DIENOGEST\ESTRADIOL Side Effects?

#1 Most Reported
Drug ineffective
76 reports (11.9%)
#2 Most Reported
Pregnancy on oral contraceptive
73 reports (11.4%)
#3 Most Reported
Off label use
62 reports (9.7%)

All DIENOGEST\ESTRADIOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 76 11.9% 0 12
Pregnancy on oral contraceptive 73 11.4% 0 9
Off label use 62 9.7% 0 15
Metrorrhagia 48 7.5% 0 8
Product use in unapproved indication 45 7.0% 0 12
Headache 44 6.9% 0 5
Nausea 33 5.2% 0 7
Drug dose omission 32 5.0% 0 1
Abnormal withdrawal bleeding 31 4.9% 0 6
Vomiting 27 4.2% 0 6
Abdominal pain lower 24 3.8% 1 10
Dyspnoea 24 3.8% 0 8
Pulmonary embolism 24 3.8% 1 21
Product use issue 23 3.6% 0 4
Dizziness 21 3.3% 0 5
Pain in extremity 19 3.0% 0 2
Abortion spontaneous 18 2.8% 0 1
Amenorrhoea 18 2.8% 0 2
Vaginal haemorrhage 18 2.8% 0 5
Weight increased 18 2.8% 0 3

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

Gender: 98.8% female, 1.2% male. Average age: 35.4 years. Most reports from: RU. View detailed demographics →

Is DIENOGEST\ESTRADIOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 0 1
2010 1 0 0
2011 2 0 0
2012 9 0 3
2013 12 0 3
2014 43 0 10
2015 47 0 12
2016 50 0 18
2017 33 2 8
2018 35 0 6
2019 39 0 10
2020 42 0 12
2021 28 0 7
2022 16 0 5
2023 18 0 4
2024 15 1 6
2025 15 0 5

View full timeline →

What Is DIENOGEST\ESTRADIOL Used For?

IndicationReports
Contraception 245
Menorrhagia 47
Endometriosis 33
Heavy menstrual bleeding 25
Oral contraception 25
Menstrual cycle management 22
Product used for unknown indication 17
Dysmenorrhoea 9
Ovarian cyst 9
Menstruation irregular 6

DIENOGEST\ESTRADIOL vs Alternatives: Which Is Safer?

DIENOGEST\ESTRADIOL vs DIENOGEST\ETHINYL ESTRADIOL DIENOGEST\ESTRADIOL vs DIETARY SUPPLEMENT DIENOGEST\ESTRADIOL vs DIETARY SUPPLEMENT\HERBALS DIENOGEST\ESTRADIOL vs DIETARY SUPPLEMENT\MINERALS\VITAMINS DIENOGEST\ESTRADIOL vs DIETARY SUPPLEMENT\UBIDECARENONE DIENOGEST\ESTRADIOL vs DIFELIKEFALIN DIENOGEST\ESTRADIOL vs DIFLUNISAL DIENOGEST\ESTRADIOL vs DIFLUPREDNATE DIENOGEST\ESTRADIOL vs DIGITOXIN DIENOGEST\ESTRADIOL vs DIGOXIN

Official FDA Label for DIENOGEST\ESTRADIOL

Official prescribing information from the FDA-approved drug label.