Generic name
Ursodiol: adverse event reports filed with FDA
2,363 reports list it as a suspect or interacting product, 2004–2026. Also reported as Ursodiol Capsules 300mg, Ursodiol 300mg, Ursodiol Capsules.
- 2,363
- reports as suspect product
- 0% of all reports · about 105 a year
- 346
- reports, 12 months to June 2026
- 380 in the 12 months before
- 83.9%
- marked serious by the reporter
- 57.4% across all reports
- 11.8%
- record death among outcomes, as reported
- 280 reports · not verified by FDA
2,363 adverse event reports received by FDA list ursodiol, a generic name as a suspect or interacting product, from January 2004 to June 2026. A further 17,160 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 346 reports listed it, close to the 380 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 105 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are drug ineffective (13.2%), off label use (12.9%) and maternal exposure during pregnancy (7.5%). A report can list several reactions, so shares add to more than 100%; 638 different terms appear across these reports. Drug ineffective is recorded in 13.2% of these reports, against 6.3% of all reports in the database.
83.9% of the reports are marked serious by the reporter; 11.8% record death among the outcomes and 38% record hospitalisation, as reported. 38.1% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (21.4%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Ursodiol reports recording the termall reports in the database
- Drug ineffectivethe medicine did not work as expected13.2%313
- Off label useused for a purpose or in a way not on the label12.9%304
- Maternal exposure during pregnancythe mother took the medicine during pregnancy7.5%177
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine6.7%158
- Pruritusitching5.9%139
- Exposure during pregnancythe medicine was taken during pregnancy4.5%107
- Premature babya baby born early4.4%104
- Nauseafeeling sick4%95
- Product use in unapproved indicationused for a purpose not on the label3.7%87
- Condition aggravatedthe condition being treated got worse3.5%82
- Drug interactionan interaction between medicines3.2%75
- Diarrhoealoose or frequent stools2.8%65
- Cholestasis2.7%63
- Therapy non-responderthe treatment did not work2.5%60
- Multiple organ dysfunction syndromeseveral organs failing2.5%58
- Renal failurekidney failure2.4%57
- Fatiguetiredness2.4%56
- Pneumonialung infection2.3%55
- Abdominal painstomach or belly pain2.3%54
- Pyrexiafever2.3%54
- Toxic epidermal necrolysisa severe skin reaction with peeling2.1%49
- Venoocclusive liver disease2.1%49
- Rashskin rash2%47
- Premature delivery1.9%46
- Thrombocytopenialow platelets1.9%46
- Vomitingbeing sick1.9%45
- Ascitesfluid in the abdomen1.9%44
- Abdominal discomfortstomach discomfort1.8%43
Top 30 of 638 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 36.4% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Primary biliary cholangitis | 124 | 5.2% |
| Cholestasis of pregnancy | 98 | 4.1% |
| Cholelithiasis | 75 | 3.2% |
| Cholestasis | 67 | 2.8% |
| Prophylaxis | 67 | 2.8% |
| Venoocclusive disease | 39 | 1.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,363 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Ursodiol reports |
|---|---|---|
| Tacrolimus | 204 | 8.6% |
| Cyclosporine | 198 | 8.4% |
| Prednisone | 196 | 8.3% |
| Prednisolone | 193 | 8.2% |
| Mycophenolate mofetil | 179 | 7.6% |
| Cyclophosphamide | 175 | 7.4% |
| Omeprazole | 175 | 7.4% |
| Azathioprine | 129 | 5.5% |
| Ocaliva | 126 | 5.3% |
| Fludarabine | 120 | 5.1% |
Other products listed in reports where Ursodiol is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Ursodiol | All reports |
|---|---|---|
| Reports as suspect product | 2,363 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 346 | 1,332,454 |
| Marked serious | 83.9% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 118 | 91 |
| Hospitalisation recorded, per 1,000 reports | 380 | 213 |
| Consumer-filed share | 17.8% | 45.8% |
| Top term, share of reports | Drug ineffective 13.2% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Questions about Ursodiol reports
How many adverse event reports has FDA received for Ursodiol?
2,363 reports list Ursodiol as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 346 of them arrived in the latest 12 months. Another 17,160 list it only as a concomitant medication.
What reactions are recorded in Ursodiol reports?
drug ineffective (13.2%), off label use (12.9%), maternal exposure during pregnancy (7.5%), foetal exposure during pregnancy (6.7%) and pruritus (5.9%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Ursodiol was responsible.
How serious are the reports?
83.9% are marked serious by the reporter. Among the outcomes recorded, 11.8% of reports include death and 38% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (38.1%), physician (35.9%) and consumer or non-health professional (17.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Ursodiol rising?
346 reports in the 12 months to June 2026, close to the 380 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Ursodiol was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Ursodiol?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Ursodiol as a suspect or interacting product; reports listing it only as a concomitant medication (17,160) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.