What the label lists and what reports show
Ursodiol side effects
Ursodiol's FDA label lists its adverse reactions in its own words. FAERS holds 21,659 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pruritus (1,302 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the ursodiol FDA label on DailyMed (effective July 31, 2023, Actavis Pharma, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe nature and frequency of adverse experiences were similar across all groups.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the Urso 250 label published by Allergan, Inc. of January 12, 2023; the label quoted above does not print one.
| Placebo n (%) | UDCA n (%) | Placebo n (%) |
|---|---|---|
| --- | 1 (1.32) | --- |
| --- | 1 (1.32) | --- |
| --- | 2 (2.63) | --- |
| --- | 1 (1.32) | --- |
| --- | 2 (2.63) | --- |
| --- | 1 (1.32) | --- |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Actavis Pharma, Inc., effective July 31, 2023 (SPL set a061bb07-a85d-4b08-877f-ce02156f0de7), via openFDA; the full label on DailyMed
What do FAERS reports show?
21,659 reports list ursodiol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,988 are coded as a death and 9,894 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ursodiol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions