SELADELPAR: 98 Adverse Event Reports & Safety Profile
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98
Total FAERS Reports
15 (15.3%)
Deaths Reported
27
Hospitalizations
98
As Primary/Secondary Suspect
5
Disabilities
First Report: 20180901 · Latest Report: 20250827
What Are the Most Common SELADELPAR Side Effects?
#1 Most Reported
Death
15 reports (15.3%)
#2 Most Reported
Pruritus
11 reports (11.2%)
#3 Most Reported
Dizziness
7 reports (7.1%)
All SELADELPAR Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 15 | 15.3% | 15 | 1 |
| Pruritus | 11 | 11.2% | 0 | 2 |
| Dizziness | 7 | 7.1% | 0 | 2 |
| Fatigue | 6 | 6.1% | 0 | 0 |
| Diarrhoea | 5 | 5.1% | 0 | 1 |
| Product dose omission issue | 5 | 5.1% | 0 | 5 |
Who Reports SELADELPAR Side Effects? Age & Gender Data
Gender: 84.6% female, 15.4% male. Average age: 64.0 years. Most reports from: US. View detailed demographics →
Is SELADELPAR Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2018 | 1 | 0 | 0 |
| 2024 | 10 | 2 | 0 |
| 2025 | 23 | 6 | 5 |
What Is SELADELPAR Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 62 |
| Primary biliary cholangitis | 36 |
Official FDA Label for SELADELPAR
Official prescribing information from the FDA-approved drug label.