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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is DYDROGESTERONE Used For?
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Official FDA Label for DYDROGESTERONE
Official prescribing information from the FDA-approved drug label.