BISULEPIN: 44 Adverse Event Reports & Safety Profile
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44
Total FAERS Reports
0
Deaths Reported
35
Hospitalizations
44
As Primary/Secondary Suspect
14
Life-Threatening
13
Disabilities
First Report: 2014 · Latest Report: 20210917
What Are the Most Common BISULEPIN Side Effects?
#1 Most Reported
Suicide attempt
12 reports (27.3%)
#2 Most Reported
Intentional overdose
12 reports (27.3%)
#3 Most Reported
Foetal growth restriction
11 reports (25.0%)
All BISULEPIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Intentional overdose | 12 | 27.3% | 0 | 12 |
| Suicide attempt | 12 | 27.3% | 0 | 12 |
| Foetal growth restriction | 11 | 25.0% | 0 | 11 |
| Oligohydramnios | 10 | 22.7% | 0 | 10 |
| Premature baby | 10 | 22.7% | 0 | 10 |
| Maternal exposure during pregnancy | 8 | 18.2% | 0 | 8 |
| Foetal exposure during pregnancy | 5 | 11.4% | 0 | 5 |
| No adverse event | 5 | 11.4% | 0 | 4 |
Who Reports BISULEPIN Side Effects? Age & Gender Data
Gender: 83.3% female, 16.7% male. Average age: 38.9 years. Most reports from: SK. View detailed demographics →
Is BISULEPIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 1 |
| 2016 | 1 | 0 | 1 |
| 2018 | 14 | 0 | 13 |
| 2019 | 3 | 0 | 3 |
| 2020 | 5 | 0 | 5 |
| 2021 | 9 | 0 | 8 |
What Is BISULEPIN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 19 |
Official FDA Label for BISULEPIN
Official prescribing information from the FDA-approved drug label.