SULPROSTONE: 34 Adverse Event Reports & Safety Profile
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34
Total FAERS Reports
3 (8.8%)
Deaths Reported
22
Hospitalizations
34
As Primary/Secondary Suspect
14
Life-Threatening
1
Disabilities
First Report: 201201 · Latest Report: 20241204
What Are the Most Common SULPROSTONE Side Effects?
#1 Most Reported
Renal cortical necrosis
10 reports (29.4%)
#2 Most Reported
Cardio-respiratory arrest
8 reports (23.5%)
#3 Most Reported
Dialysis
5 reports (14.7%)
All SULPROSTONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Renal cortical necrosis | 10 | 29.4% | 3 | 10 |
| Cardio-respiratory arrest | 8 | 23.5% | 1 | 1 |
| Acute kidney injury | 5 | 14.7% | 0 | 5 |
| Dialysis | 5 | 14.7% | 3 | 5 |
Who Reports SULPROSTONE Side Effects? Age & Gender Data
Gender: 100.0% female, 0.0% male. Average age: 32.9 years. Most reports from: FR. View detailed demographics →
Is SULPROSTONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 4 | 0 | 4 |
| 2013 | 1 | 0 | 1 |
| 2016 | 2 | 2 | 2 |
| 2017 | 3 | 0 | 3 |
| 2018 | 7 | 0 | 0 |
| 2020 | 1 | 0 | 1 |
| 2022 | 2 | 0 | 0 |
| 2024 | 5 | 0 | 5 |
What Is SULPROSTONE Used For?
| Indication | Reports |
|---|---|
| Postpartum haemorrhage | 11 |
| Uterine atony | 5 |
Official FDA Label for SULPROSTONE
Official prescribing information from the FDA-approved drug label.