DROSPIRENONE\ESTRADIOL: 131 Adverse Event Reports & Safety Profile
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131
Total FAERS Reports
6 (4.6%)
Deaths Reported
37
Hospitalizations
131
As Primary/Secondary Suspect
3
Disabilities
First Report: 2009 · Latest Report: 20250404
What Are the Most Common DROSPIRENONE\ESTRADIOL Side Effects?
#1 Most Reported
Hot flush
8 reports (6.1%)
#2 Most Reported
Vaginal haemorrhage
7 reports (5.3%)
#3 Most Reported
Malaise
7 reports (5.3%)
All DROSPIRENONE\ESTRADIOL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hot flush | 8 | 6.1% | 0 | 0 |
| Abdominal pain | 7 | 5.3% | 0 | 3 |
| Malaise | 7 | 5.3% | 0 | 4 |
| Vaginal haemorrhage | 7 | 5.3% | 0 | 3 |
| Anxiety | 6 | 4.6% | 0 | 1 |
| Off label use | 5 | 3.8% | 0 | 1 |
| Postmenopausal haemorrhage | 5 | 3.8% | 0 | 2 |
| Uterine haemorrhage | 5 | 3.8% | 0 | 2 |
Who Reports DROSPIRENONE\ESTRADIOL Side Effects? Age & Gender Data
Gender: 98.7% female, 1.3% male. Average age: 57.2 years. Most reports from: RU. View detailed demographics →
Is DROSPIRENONE\ESTRADIOL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 0 | 1 |
| 2011 | 1 | 0 | 1 |
| 2013 | 1 | 0 | 0 |
| 2014 | 3 | 0 | 0 |
| 2015 | 3 | 0 | 1 |
| 2016 | 2 | 0 | 1 |
| 2017 | 5 | 0 | 2 |
| 2018 | 5 | 2 | 1 |
| 2019 | 2 | 1 | 1 |
| 2020 | 4 | 0 | 1 |
| 2021 | 6 | 0 | 3 |
| 2022 | 2 | 0 | 1 |
| 2023 | 5 | 0 | 0 |
| 2024 | 1 | 0 | 0 |
| 2025 | 8 | 1 | 3 |
What Is DROSPIRENONE\ESTRADIOL Used For?
| Indication | Reports |
|---|---|
| Hormone replacement therapy | 25 |
| Menopausal symptoms | 13 |
| Hot flush | 12 |
| Menopause | 7 |
DROSPIRENONE\ESTRADIOL vs Alternatives: Which Is Safer?
DROSPIRENONE\ESTRADIOL vs DROSPIRENONE\ETHINYL ESTRADIOL
DROSPIRENONE\ESTRADIOL vs DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE
DROSPIRENONE\ESTRADIOL vs DROTAVERINE
DROSPIRENONE\ESTRADIOL vs DROXIDOPA
DROSPIRENONE\ESTRADIOL vs DULAGLUTIDE
DROSPIRENONE\ESTRADIOL vs DULERA
DROSPIRENONE\ESTRADIOL vs DULOXETINE
DROSPIRENONE\ESTRADIOL vs DUPILUMAB
DROSPIRENONE\ESTRADIOL vs DURAGESIC
DROSPIRENONE\ESTRADIOL vs DUROGESIC
Official FDA Label for DROSPIRENONE\ESTRADIOL
Official prescribing information from the FDA-approved drug label.