ALPROSTADIL ALFADEX: 45 Adverse Event Reports & Safety Profile
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45
Total FAERS Reports
15 (33.3%)
Deaths Reported
26
Hospitalizations
45
As Primary/Secondary Suspect
4
Life-Threatening
2
Disabilities
First Report: 19961201 · Latest Report: 20230601
What Are the Most Common ALPROSTADIL ALFADEX Side Effects?
#1 Most Reported
Stevens-johnson syndrome
9 reports (20.0%)
#2 Most Reported
Toxic epidermal necrolysis
7 reports (15.6%)
#3 Most Reported
Sepsis
7 reports (15.6%)
All ALPROSTADIL ALFADEX Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Stevens-johnson syndrome | 9 | 20.0% | 7 | 3 |
| Sepsis | 7 | 15.6% | 5 | 6 |
| Toxic epidermal necrolysis | 7 | 15.6% | 7 | 2 |
| Peripheral arterial occlusive disease | 6 | 13.3% | 1 | 6 |
| Right ventricular failure | 6 | 13.3% | 5 | 6 |
| Anal polyp | 5 | 11.1% | 0 | 5 |
| Blood pressure abnormal | 5 | 11.1% | 0 | 5 |
| Cardiac dysfunction | 5 | 11.1% | 5 | 5 |
| Dermatitis allergic | 5 | 11.1% | 0 | 5 |
| Disease progression | 5 | 11.1% | 5 | 5 |
| Duodenitis | 5 | 11.1% | 0 | 5 |
| Galectin-3 increased | 5 | 11.1% | 5 | 5 |
| Gastritis | 5 | 11.1% | 0 | 5 |
| Left ventricular dysfunction | 5 | 11.1% | 5 | 5 |
| Multiple organ dysfunction syndrome | 5 | 11.1% | 5 | 5 |
| Myocardial fibrosis | 5 | 11.1% | 5 | 5 |
| Myocarditis | 5 | 11.1% | 5 | 5 |
| Pneumonia | 5 | 11.1% | 5 | 5 |
| Rectal haemorrhage | 5 | 11.1% | 0 | 5 |
| Respiratory failure | 5 | 11.1% | 5 | 5 |
Who Reports ALPROSTADIL ALFADEX Side Effects? Age & Gender Data
Gender: 68.3% female, 31.7% male. Average age: 56.1 years. Most reports from: DE. View detailed demographics →
Is ALPROSTADIL ALFADEX Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 0 |
| 2013 | 1 | 0 | 0 |
| 2015 | 1 | 1 | 1 |
| 2016 | 2 | 0 | 2 |
| 2017 | 1 | 0 | 0 |
| 2019 | 1 | 0 | 1 |
| 2020 | 4 | 0 | 1 |
| 2021 | 5 | 0 | 5 |
| 2022 | 1 | 0 | 0 |
| 2023 | 1 | 0 | 1 |
What Is ALPROSTADIL ALFADEX Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 17 |
| Poor peripheral circulation | 6 |
| Systemic scleroderma | 6 |
Official FDA Label for ALPROSTADIL ALFADEX
Official prescribing information from the FDA-approved drug label.