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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.

DYDROGESTERONE: 340 Adverse Event Reports & Safety Profile

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340
Total FAERS Reports
13 (3.8%)
Deaths Reported
112
Hospitalizations
340
As Primary/Secondary Suspect
15
Life-Threatening
7
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status

FDA Application: 017388 ·

First Report: 1992 · Latest Report: 20250622

What Are the Most Common DYDROGESTERONE Side Effects?

#1 Most Reported
Maternal exposure during pregnancy
117 reports (34.4%)
#2 Most Reported
Abortion spontaneous
93 reports (27.4%)
#3 Most Reported
Ovarian hyperstimulation syndrome
34 reports (10.0%)

All DYDROGESTERONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Maternal exposure during pregnancy 117 34.4% 2 8
Abortion spontaneous 93 27.4% 0 0
Ovarian hyperstimulation syndrome 34 10.0% 0 28
Foetal exposure during pregnancy 27 7.9% 2 1
Exposure during pregnancy 20 5.9% 0 6
Off label use 18 5.3% 0 13
Meningioma 17 5.0% 0 9
Premature baby 16 4.7% 1 1
Product use in unapproved indication 15 4.4% 0 8
Toxicity to various agents 11 3.2% 0 0
Vaginal haemorrhage 11 3.2% 0 10
Ascites 10 2.9% 0 7
Headache 10 2.9% 0 0
Intentional self-injury 10 2.9% 0 0
Low birth weight baby 10 2.9% 0 1
Placenta accreta 10 2.9% 0 9
Vomiting 10 2.9% 0 9
Premature delivery 9 2.7% 0 1
Drug use disorder 8 2.4% 0 0
Pelvic infection 8 2.4% 0 8

Who Reports DYDROGESTERONE Side Effects? Age & Gender Data

Gender: 94.4% female, 5.6% male. Average age: 33.8 years. Most reports from: AE. View detailed demographics →

Is DYDROGESTERONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 1
2007 1 0 1
2010 1 0 1
2011 3 0 3
2012 2 0 1
2013 1 0 1
2014 4 1 1
2015 2 0 0
2016 4 0 3
2017 23 3 4
2018 23 2 16
2019 14 2 10
2020 6 0 5
2021 5 0 3
2022 12 0 8
2023 9 4 0
2024 9 0 4
2025 17 0 13

View full timeline →

What Is DYDROGESTERONE Used For?

IndicationReports
Hormone replacement therapy 99
Product used for unknown indication 48
Assisted reproductive technology 26
In vitro fertilisation 26
Luteal phase deficiency 12
Foetal exposure during pregnancy 9
Intentional self-injury 8
Infertility 6
Abortion spontaneous 5
Amenorrhoea 5

DYDROGESTERONE vs Alternatives: Which Is Safer?

DYDROGESTERONE vs EBASTINE DYDROGESTERONE vs ECALLANTIDE DYDROGESTERONE vs ECONAZOLE DYDROGESTERONE vs ECULIZUMAB DYDROGESTERONE vs EDARAVONE DYDROGESTERONE vs EDETATE DYDROGESTERONE vs EDOXABAN DYDROGESTERONE vs EDOXABAN TOSILATE DYDROGESTERONE vs EFALIZUMAB DYDROGESTERONE vs EFANESOCTOCOG ALFA

Official FDA Label for DYDROGESTERONE

Official prescribing information from the FDA-approved drug label.