URSODEOXYCHOLIC ACID: 26 Adverse Event Reports & Safety Profile
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26
Total FAERS Reports
1 (3.8%)
Deaths Reported
16
Hospitalizations
26
As Primary/Secondary Suspect
1
Life-Threatening
First Report: 200604 · Latest Report: 201405
What Are the Most Common URSODEOXYCHOLIC ACID Side Effects?
#1 Most Reported
Suicide attempt
8 reports (30.8%)
#2 Most Reported
Sopor
8 reports (30.8%)
#3 Most Reported
Eyelid oedema
8 reports (30.8%)
All URSODEOXYCHOLIC ACID Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Disorientation | 8 | 30.8% | 0 | 8 |
| Eyelid oedema | 8 | 30.8% | 0 | 8 |
| Sopor | 8 | 30.8% | 0 | 8 |
| Suicide attempt | 8 | 30.8% | 0 | 8 |
| Drug abuse | 7 | 26.9% | 0 | 7 |
Who Reports URSODEOXYCHOLIC ACID Side Effects? Age & Gender Data
Average age: 46.0 years. Most reports from: IT. View detailed demographics →
Is URSODEOXYCHOLIC ACID Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 1 | 0 | 1 |
| 2010 | 1 | 0 | 0 |
| 2012 | 2 | 0 | 1 |
| 2013 | 3 | 0 | 2 |
| 2014 | 9 | 0 | 8 |
What Is URSODEOXYCHOLIC ACID Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 14 |
Official FDA Label for URSODEOXYCHOLIC ACID
Official prescribing information from the FDA-approved drug label.