ADEMPAS: 58 Adverse Event Reports & Safety Profile
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58
Total FAERS Reports
3 (5.2%)
Deaths Reported
20
Hospitalizations
58
As Primary/Secondary Suspect
First Report: 20131126 · Latest Report: 20230405
What Are the Most Common ADEMPAS Side Effects?
#1 Most Reported
Dyspnoea
8 reports (13.8%)
#2 Most Reported
Oedema
7 reports (12.1%)
#3 Most Reported
Headache
7 reports (12.1%)
All ADEMPAS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Dyspnoea | 8 | 13.8% | 0 | 3 |
| Headache | 7 | 12.1% | 0 | 2 |
| Oedema | 7 | 12.1% | 1 | 5 |
| Dizziness | 6 | 10.3% | 0 | 2 |
| Oedema peripheral | 6 | 10.3% | 1 | 3 |
| Nausea | 5 | 8.6% | 0 | 3 |
Who Reports ADEMPAS Side Effects? Age & Gender Data
Gender: 100.0% female, 0.0% male. Average age: 59.4 years. Most reports from: US. View detailed demographics →
Is ADEMPAS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 3 | 0 | 1 |
| 2014 | 14 | 3 | 8 |
| 2023 | 1 | 0 | 1 |
What Is ADEMPAS Used For?
| Indication | Reports |
|---|---|
| Pulmonary arterial hypertension | 18 |
| Pulmonary hypertension | 12 |
| Product used for unknown indication | 8 |
Official FDA Label for ADEMPAS
Official prescribing information from the FDA-approved drug label.