PROMEGESTONE: 19 Adverse Event Reports & Safety Profile
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19
Total FAERS Reports
3 (15.8%)
Deaths Reported
10
Hospitalizations
19
As Primary/Secondary Suspect
1
Life-Threatening
8
Disabilities
First Report: 20051015 · Latest Report: 20210906
What Are the Most Common PROMEGESTONE Side Effects?
#1 Most Reported
Meningioma
12 reports (63.2%)
#2 Most Reported
Asthenia
7 reports (36.8%)
#3 Most Reported
Disturbance in attention
6 reports (31.6%)
All PROMEGESTONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Meningioma | 12 | 63.2% | 0 | 9 |
| Asthenia | 7 | 36.8% | 0 | 7 |
| Disturbance in attention | 6 | 31.6% | 0 | 6 |
| Aphasia | 5 | 26.3% | 0 | 5 |
| Cognitive disorder | 5 | 26.3% | 0 | 5 |
| Language disorder | 5 | 26.3% | 0 | 5 |
| Malaise | 5 | 26.3% | 0 | 5 |
| Reading disorder | 5 | 26.3% | 0 | 5 |
Who Reports PROMEGESTONE Side Effects? Age & Gender Data
Gender: 100.0% female, 0.0% male. Average age: 48.0 years. Most reports from: FR. View detailed demographics →
Is PROMEGESTONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 1 | 0 | 0 |
| 2010 | 1 | 0 | 1 |
| 2012 | 1 | 0 | 1 |
| 2016 | 3 | 0 | 2 |
| 2017 | 5 | 3 | 0 |
| 2019 | 3 | 0 | 1 |
| 2021 | 5 | 0 | 5 |
What Is PROMEGESTONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 8 |
| Endometriosis | 5 |
Official FDA Label for PROMEGESTONE
Official prescribing information from the FDA-approved drug label.