Ursodeoxycholic acid adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Ursodeoxycholic acid
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Also reported as: Ursodeoxycholic Acid Tablet 50mg, Ursodeoxycholic Acid Tablet, Ursodeoxycholic Acid Tablets

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2004 to September 2021, FDA received 723 adverse event reports that name Ursodeoxycholic acid. In these reports the drug is a suspect or interacting product.

In the same period, 4,307 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 0 reports in the 12 months to June 2026 and 0 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Reports from consumers or other non-health professionals were 10.8% of the reports that name Ursodeoxycholic acid and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Ursodeoxycholic acid is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

FDA received no report that names Ursodeoxycholic acid in April to June 2026, in January to March 2026 or in April to June 2025.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 110 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 680 of the 723 reports (94.1%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 110 terms.

Reaction terms in the reports that name Ursodeoxycholic acid, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 723 reports
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	95	13.1%
Drug ineffectivethe medicine did not work as expected	59	8.2%
Premature babya baby born early	53	7.3%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	52	7.2%
Product use in unapproved indicationused for a purpose not on the label	45	6.2%
Off label useused for a purpose or in a way not on the label	39	5.4%
Exposure during pregnancythe medicine was taken during pregnancy	29	4%
Pneumonialung infection	26	3.6%
Pulmonary malformation	26	3.6%
Pyrexiafever	25	3.5%
Pruritusitching	24	3.3%
Cholestasis	23	3.2%
Drug-induced liver injury	23	3.2%
Low birth weight baby	23	3.2%
Gastrointestinal infection	22	3%
Maternal exposure during breast feeding	22	3%
Cytomegalovirus viraemia	20	2.8%
Drug interactionan interaction between medicines	20	2.8%
Renal impairmentreduced kidney function	20	2.8%
Somnolencedrowsiness	20	2.8%
Condition aggravatedthe condition being treated got worse	19	2.6%
Jaundiceyellowing of the skin or eyes	19	2.6%
Ascitesfluid in the abdomen	18	2.5%
Nauseafeeling sick	18	2.5%
Premature delivery	18	2.5%
Diarrhoealoose or frequent stools	17	2.4%
Cholestasis of pregnancy	16	2.2%
Lung cyst	16	2.2%
Alanine aminotransferase increasedraised liver enzyme (ALT)	15	2.1%
Disorientation	15	2.1%
Dyspnoeashortness of breath	14	1.9%
Eyelid oedemaa swollen eyelid	14	1.9%
Suicide attempta suicide attempt	14	1.9%
Anaemialow red blood cells	13	1.8%
Exposure via breast milk	13	1.8%
General physical health deteriorationgeneral decline in health	13	1.8%
Multiple organ dysfunction syndromeseveral organs failing	13	1.8%
Rashskin rash	13	1.8%
Sopor	13	1.8%
Bile duct stone	12	1.7%
Drug abusemisuse of a medicine	12	1.7%
Drug eruption	12	1.7%
Fatiguetiredness	12	1.7%
Headachehead pain	12	1.7%
Thrombocytopenialow platelets	12	1.7%
Blood alkaline phosphatase increased	11	1.5%
Cystitis haemorrhagic	11	1.5%
Erythemaskin redness	11	1.5%
Oesophagitis	11	1.5%
Respiratory tract malformation	11	1.5%

Download all 110 terms of Ursodeoxycholic acid (CSV)

The counts add to more than 723 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Ursodeoxycholic acid, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	5	5	0	0	3	0	0	3	0
2005	11	11	0	0	0	0	0	11	0
2006	1	1	0	0	1	0	0	1	0
2007	2	2	2	0	0	0	0	0	0
2008	2	2	1	1	0	0	1	1	0
2009	2	2	0	0	0	0	0	2	0
2010	8	8	3	2	0	0	0	3	0
2011	2	2	0	0	1	0	0	1	0
2012	8	8	2	0	5	0	0	3	0
2013	43	42	4	3	27	0	1	23	1
2014	77	76	11	3	46	0	7	42	1
2015	49	49	7	2	17	9	1	36	0
2016	41	38	6	4	18	0	0	26	3
2017	45	44	10	9	16	2	0	38	1
2018	91	89	27	19	20	0	3	72	2
2019	119	118	20	3	30	2	9	89	1
2020	66	61	6	3	20	1	8	55	5
2021	151	143	18	1	35	0	12	125	8
2022	0	0	0	0	0	0	0	0	0
2026	0	0	0	0	0	0	0	0	0

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Ursodeoxycholic acid, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Ursodeoxycholic acid, by the year in which FDA received them
Year	Reports
2004	5
2005	11
2006	1
2007	2
2008	3
2009	1
2010	10
2011	3
2012	17
2013	40
2014	74
2015	49
2016	48
2017	44
2018	102
2019	106
2020	70
2021	137

Reports that name Ursodeoxycholic acid, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Ursodeoxycholic acid
Age	Reports	Share
Under 2	24	3.3%
2 to 11	47	6.5%
12 to 17	17	2.4%
18 to 44	151	20.9%
45 to 64	147	20.3%
65 to 74	58	8%
75 and over	44	6.1%
Age not given	235	32.5%

Sex of the patient in the reports that name Ursodeoxycholic acid
Sex	Reports	Share
Female	292	40.4%
Male	276	38.2%
Unknown or not given	155	21.4%

Type of reporter in the reports that name Ursodeoxycholic acid
Reporter	Reports	Share
Physician	182	25.2%
Pharmacist	29	4%
Other health professional	391	54.1%
Lawyer	0	0%
Consumer or non-health professional	78	10.8%
Not given	43	5.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 10.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Ursodeoxycholic acid record
Indication as recorded (MedDRA)	Reports	Share
Prophylaxis	77	10.7%
Cholestasis	33	4.6%
Cholestasis of pregnancy	32	4.4%
Foetal exposure during pregnancy	29	4%
Primary biliary cholangitis	19	2.6%
Cholelithiasis	15	2.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 723 reports.

Drugs in the same reports

Other drugs that the reports of Ursodeoxycholic acid name, in any role, in order of name
Drug	Reports that name the two
Azathioprine	63
Cyclophosphamide	51
Domperidone	44
Furosemide	64
Levothyroxine	41
Methotrexate	44
Mycophenolate mofetil	88
Omeprazole	47
Prednisolone	51
Prednisone	39

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for Ursodeoxycholic acidThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Ursodeoxycholic acid: adverse event reports that FDA received. https://reportedreactions.com/drug/ursodeoxycholic-acid/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Ursodeoxycholic acid as a suspect or interacting product. The 4,307 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Ursodeoxycholic acid was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Ursodeoxycholic acid?

No. It is a count of what people reported to FDA: 723 reports from February 2004 to September 2021. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (54.1%), physician (25.2%) and consumer or non-health professional (10.8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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