Drug Safety Information for URSODIOL (Ursodiol)

Safety-related Labeling Changes for ACTIGALL (URSODIOL) Rx Drug: FDA Link

There have been rare postmarketing reports of ursodiol-treated patients who developed enteroliths (bezoars) resulting in obstructive symptoms that required surgical intervention. If a patient presents with obstructive gastrointestinal symptoms, hold Actigall until a clinical evaluation has been conducted.

Safety-related Labeling Changes for URSO 250 (URSODIOL) Rx Drug: FDA Link

Safety-related Labeling Changes for URSO FORTE (URSODIOL) Rx Drug: FDA Link

Adverse Drug Reactions for URSODIOL* (Ursodiol)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with URSODIOL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia679
2Anaemia517
3Platelet count decreased516
4Hepatic function abnormal479
5Diarrhoea*466
6Decreased appetite414
7White blood cell count decreased410
8Nausea402
9Haemoglobin decreased374
10Rash345
11Vomiting313
12Renal impairment308
13Pneumonia306
14Malaise300
15Aspartate aminotransferase increased298
16Alanine aminotransferase increased293
17Sepsis288
18Liver disorder285
19Interstitial lung disease263
20Ascites262

* This side effect also appears in "Top 10 Side Effects of URSODIOL " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking URSODIOL
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication2914
2Hepatitis c1966
3Prophylaxis1853
4Liver disorder1125
5Cholelithiasis738
6Hepatic function abnormal694
7Biliary cirrhosis primary*559
8Hepatic cirrhosis524
9Cholestasis403
10Chronic hepatitis247

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for URSODIOL

Total Reports Filed with FDA: 41642


Number of FDA Adverse Event Reports by Patient Age for URSODIOL

Total Reports Filed with FDA: 41642*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ursodiol (Ursolvan, Urso, Ursobilane, Ursolite, Ursodiol capsules, Delursan, Ursochol, Urso 250, Ursodiol, Urso forte, Actigall)

Charts are based on 41642 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and URSODIOL Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.