MONTEPLASE: 15 Adverse Event Reports & Safety Profile
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15
Total FAERS Reports
6 (40.0%)
Deaths Reported
5
Hospitalizations
15
As Primary/Secondary Suspect
2
Life-Threatening
First Report: 20161124 · Latest Report: 20220221
What Are the Most Common MONTEPLASE Side Effects?
#1 Most Reported
Hydrops foetalis
4 reports (26.7%)
#2 Most Reported
Foetal exposure during pregnancy
4 reports (26.7%)
#3 Most Reported
Drug ineffective
3 reports (20.0%)
All MONTEPLASE Side Effects by Frequency
No side effect data available.
Who Reports MONTEPLASE Side Effects? Age & Gender Data
Gender: 85.7% female, 14.3% male. Average age: 64.1 years. Most reports from: JP. View detailed demographics →
Is MONTEPLASE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2016 | 1 | 1 | 1 |
| 2017 | 1 | 1 | 0 |
| 2019 | 1 | 0 | 1 |
| 2022 | 1 | 1 | 0 |
What Is MONTEPLASE Used For?
| Indication | Reports |
|---|---|
| Pulmonary embolism | 10 |
Official FDA Label for MONTEPLASE
Official prescribing information from the FDA-approved drug label.