ETRETINATE: 26 Adverse Event Reports & Safety Profile
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26
Total FAERS Reports
2 (7.7%)
Deaths Reported
9
Hospitalizations
26
As Primary/Secondary Suspect
3
Life-Threatening
Sep 30, 1986
FDA Approved
Discontinued
Status
FDA Application: 019369 ·
First Report: 200311 · Latest Report: 20250213
What Are the Most Common ETRETINATE Side Effects?
#1 Most Reported
Breast cancer
7 reports (26.9%)
#2 Most Reported
Renal impairment
5 reports (19.2%)
#3 Most Reported
Pustular psoriasis
3 reports (11.5%)
All ETRETINATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Breast cancer | 7 | 26.9% | 0 | 1 |
| Renal impairment | 5 | 19.2% | 1 | 3 |
Who Reports ETRETINATE Side Effects? Age & Gender Data
Gender: 68.6% female, 31.4% male. Average age: 62.1 years. Most reports from: JP. View detailed demographics →
Is ETRETINATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 0 |
| 2012 | 1 | 0 | 1 |
| 2014 | 1 | 0 | 0 |
| 2015 | 1 | 0 | 0 |
| 2017 | 2 | 0 | 0 |
| 2018 | 3 | 0 | 2 |
| 2019 | 1 | 0 | 0 |
| 2021 | 3 | 1 | 3 |
| 2024 | 2 | 1 | 1 |
| 2025 | 1 | 0 | 1 |
What Is ETRETINATE Used For?
| Indication | Reports |
|---|---|
| Psoriasis | 13 |
| Psoriatic arthropathy | 6 |
Official FDA Label for ETRETINATE
Official prescribing information from the FDA-approved drug label.