ESAXERENONE: 47 Adverse Event Reports & Safety Profile
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47
Total FAERS Reports
0
Deaths Reported
30
Hospitalizations
47
As Primary/Secondary Suspect
14
Life-Threatening
1
Disabilities
First Report: 20200615 · Latest Report: 20250709
What Are the Most Common ESAXERENONE Side Effects?
#1 Most Reported
Compartment syndrome
19 reports (40.4%)
#2 Most Reported
Angioedema
19 reports (40.4%)
#3 Most Reported
Intentional overdose
14 reports (29.8%)
All ESAXERENONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Angioedema | 19 | 40.4% | 0 | 18 |
| Compartment syndrome | 19 | 40.4% | 0 | 18 |
| Intentional overdose | 14 | 29.8% | 0 | 13 |
| Hypotension | 12 | 25.5% | 0 | 10 |
| Acute kidney injury | 11 | 23.4% | 0 | 10 |
| Haemodynamic instability | 8 | 17.0% | 0 | 7 |
| Nausea | 7 | 14.9% | 0 | 7 |
| Coma | 6 | 12.8% | 0 | 6 |
| Hyperkalaemia | 6 | 12.8% | 0 | 4 |
| Overdose | 6 | 12.8% | 0 | 5 |
| Vomiting | 6 | 12.8% | 0 | 6 |
| Renal impairment | 5 | 10.6% | 0 | 3 |
| Shock | 5 | 10.6% | 0 | 5 |
| Toxicity to various agents | 5 | 10.6% | 0 | 4 |
Who Reports ESAXERENONE Side Effects? Age & Gender Data
Gender: 66.7% female, 33.3% male. Average age: 68.3 years. Most reports from: JP. View detailed demographics →
Is ESAXERENONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2020 | 3 | 0 | 1 |
| 2021 | 2 | 0 | 2 |
| 2022 | 2 | 0 | 2 |
| 2023 | 4 | 0 | 0 |
| 2024 | 5 | 0 | 4 |
| 2025 | 1 | 0 | 1 |
What Is ESAXERENONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 29 |
| Hypertension | 16 |
Official FDA Label for ESAXERENONE
Official prescribing information from the FDA-approved drug label.