ETHAMSYLATE: 73 Adverse Event Reports & Safety Profile
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73
Total FAERS Reports
7 (9.6%)
Deaths Reported
50
Hospitalizations
73
As Primary/Secondary Suspect
16
Life-Threatening
14
Disabilities
First Report: 200903 · Latest Report: 20240717
What Are the Most Common ETHAMSYLATE Side Effects?
#1 Most Reported
Premature baby
13 reports (17.8%)
#2 Most Reported
Foetal growth restriction
12 reports (16.4%)
#3 Most Reported
Drug ineffective
12 reports (16.4%)
All ETHAMSYLATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Premature baby | 13 | 17.8% | 0 | 10 |
| Drug ineffective | 12 | 16.4% | 0 | 9 |
| Foetal growth restriction | 12 | 16.4% | 0 | 11 |
| Oligohydramnios | 11 | 15.1% | 0 | 10 |
| Off label use | 10 | 13.7% | 1 | 9 |
| Asthenia | 9 | 12.3% | 0 | 8 |
| Colitis ulcerative | 9 | 12.3% | 0 | 4 |
| Foetal exposure during pregnancy | 9 | 12.3% | 0 | 5 |
| Maternal exposure during pregnancy | 9 | 12.3% | 0 | 8 |
| Diarrhoea | 8 | 11.0% | 0 | 3 |
| Dizziness | 8 | 11.0% | 0 | 8 |
| Abnormal behaviour | 7 | 9.6% | 1 | 7 |
| Disturbance in attention | 7 | 9.6% | 0 | 6 |
| Heavy menstrual bleeding | 7 | 9.6% | 0 | 7 |
| Memory impairment | 7 | 9.6% | 0 | 6 |
| Skin lesion | 7 | 9.6% | 0 | 7 |
| Allodynia | 6 | 8.2% | 0 | 6 |
| Balance disorder | 6 | 8.2% | 0 | 6 |
| Covid-19 | 6 | 8.2% | 0 | 6 |
| Crying | 6 | 8.2% | 0 | 6 |
Who Reports ETHAMSYLATE Side Effects? Age & Gender Data
Gender: 81.1% female, 18.9% male. Average age: 36.4 years. Most reports from: PL. View detailed demographics →
Is ETHAMSYLATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 2 | 0 | 0 |
| 2012 | 1 | 0 | 1 |
| 2014 | 1 | 0 | 0 |
| 2015 | 7 | 1 | 7 |
| 2017 | 2 | 1 | 0 |
| 2018 | 14 | 1 | 13 |
| 2019 | 2 | 1 | 2 |
| 2020 | 5 | 0 | 5 |
| 2022 | 2 | 0 | 2 |
| 2023 | 6 | 0 | 5 |
| 2024 | 2 | 0 | 0 |
What Is ETHAMSYLATE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 22 |
| Pyoderma gangrenosum | 7 |
Official FDA Label for ETHAMSYLATE
Official prescribing information from the FDA-approved drug label.