DROSPIRENONE\ESTETROL: 191 Adverse Event Reports & Safety Profile
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191
Total FAERS Reports
0
Deaths Reported
8
Hospitalizations
191
As Primary/Secondary Suspect
3
Life-Threatening
2
Disabilities
Active Ingredient: DROSPIRENONE\ESTETROL MONOHYDRATE ·
First Report: 20211001 · Latest Report: 20250701
What Are the Most Common DROSPIRENONE\ESTETROL Side Effects?
#1 Most Reported
Intermenstrual bleeding
23 reports (12.0%)
#2 Most Reported
Heavy menstrual bleeding
16 reports (8.4%)
#3 Most Reported
Mood swings
10 reports (5.2%)
All DROSPIRENONE\ESTETROL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Intermenstrual bleeding | 23 | 12.0% | 0 | 0 |
| Heavy menstrual bleeding | 16 | 8.4% | 0 | 0 |
| Headache | 10 | 5.2% | 0 | 2 |
| Mood swings | 10 | 5.2% | 0 | 0 |
| Menstruation irregular | 8 | 4.2% | 0 | 0 |
| Migraine | 8 | 4.2% | 0 | 1 |
| Nausea | 8 | 4.2% | 0 | 0 |
| Suicidal ideation | 8 | 4.2% | 0 | 0 |
| Weight increased | 8 | 4.2% | 0 | 0 |
| Breast tenderness | 7 | 3.7% | 0 | 1 |
| Dizziness | 7 | 3.7% | 0 | 1 |
| Drug ineffective | 7 | 3.7% | 0 | 0 |
| Hypersensitivity | 6 | 3.1% | 0 | 0 |
| Pulmonary embolism | 6 | 3.1% | 0 | 1 |
| Acne | 5 | 2.6% | 0 | 0 |
| Depression | 5 | 2.6% | 0 | 0 |
| Dysmenorrhoea | 5 | 2.6% | 0 | 0 |
| Exposure during pregnancy | 5 | 2.6% | 0 | 0 |
| Palpitations | 5 | 2.6% | 0 | 1 |
| Vaginal haemorrhage | 5 | 2.6% | 0 | 0 |
Who Reports DROSPIRENONE\ESTETROL Side Effects? Age & Gender Data
Gender: 100.0% female, 0.0% male. Average age: 29.6 years. Most reports from: US. View detailed demographics →
Is DROSPIRENONE\ESTETROL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2021 | 7 | 0 | 0 |
| 2022 | 10 | 0 | 1 |
| 2023 | 9 | 0 | 3 |
| 2024 | 9 | 0 | 2 |
| 2025 | 8 | 0 | 1 |
What Is DROSPIRENONE\ESTETROL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 104 |
| Contraception | 56 |
| Heavy menstrual bleeding | 5 |
| Menstruation irregular | 5 |
DROSPIRENONE\ESTETROL vs Alternatives: Which Is Safer?
DROSPIRENONE\ESTETROL vs DROSPIRENONE\ESTRADIOL
DROSPIRENONE\ESTETROL vs DROSPIRENONE\ETHINYL ESTRADIOL
DROSPIRENONE\ESTETROL vs DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE
DROSPIRENONE\ESTETROL vs DROTAVERINE
DROSPIRENONE\ESTETROL vs DROXIDOPA
DROSPIRENONE\ESTETROL vs DULAGLUTIDE
DROSPIRENONE\ESTETROL vs DULERA
DROSPIRENONE\ESTETROL vs DULOXETINE
DROSPIRENONE\ESTETROL vs DUPILUMAB
DROSPIRENONE\ESTETROL vs DURAGESIC
Official FDA Label for DROSPIRENONE\ESTETROL
Official prescribing information from the FDA-approved drug label.