EPROSARTAN: 78 Adverse Event Reports & Safety Profile
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78
Total FAERS Reports
5 (6.4%)
Deaths Reported
38
Hospitalizations
78
As Primary/Secondary Suspect
3
Life-Threatening
1
Disabilities
Dec 22, 1997
FDA Approved
Discontinued
Status
Yes
Generic Available
FDA Application: 020738 ·
First Report: 20050728 · Latest Report: 20230309
What Are the Most Common EPROSARTAN Side Effects?
#1 Most Reported
Febrile neutropenia
12 reports (15.4%)
#2 Most Reported
Toxic skin eruption
9 reports (11.5%)
#3 Most Reported
Chills
8 reports (10.3%)
All EPROSARTAN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Febrile neutropenia | 12 | 15.4% | 0 | 12 |
| Toxic skin eruption | 9 | 11.5% | 0 | 2 |
| Blood pressure increased | 8 | 10.3% | 0 | 7 |
| Chills | 8 | 10.3% | 0 | 7 |
| Gout | 7 | 9.0% | 0 | 7 |
| Heart rate decreased | 7 | 9.0% | 0 | 7 |
| Peripheral swelling | 7 | 9.0% | 0 | 7 |
| Pyrexia | 7 | 9.0% | 0 | 7 |
| Skin discolouration | 7 | 9.0% | 0 | 7 |
| Tremor | 7 | 9.0% | 0 | 7 |
| Vomiting | 7 | 9.0% | 0 | 7 |
| Asthenia | 5 | 6.4% | 0 | 0 |
Who Reports EPROSARTAN Side Effects? Age & Gender Data
Gender: 58.7% female, 41.3% male. Average age: 70.6 years. Most reports from: ES. View detailed demographics →
Is EPROSARTAN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 2 | 0 | 2 |
| 2010 | 1 | 0 | 0 |
| 2012 | 7 | 0 | 1 |
| 2013 | 3 | 0 | 0 |
| 2014 | 5 | 0 | 3 |
| 2016 | 7 | 1 | 3 |
| 2017 | 14 | 0 | 14 |
| 2019 | 1 | 0 | 0 |
| 2021 | 1 | 1 | 0 |
| 2023 | 1 | 0 | 1 |
What Is EPROSARTAN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 34 |
| Hypertension | 24 |
| Atrial fibrillation | 7 |
Official FDA Label for EPROSARTAN
Official prescribing information from the FDA-approved drug label.