Drug · FAERS side-effect profile with label screen
Ursosiol side effects: what 19,315 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Ursodiol
openFDA label
Who reports
19,315 reports · 79% serious · 2,417 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ursodiol Capsules are indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery.
FDA label, Indications and Usage
What it is
DESCRIPTION Ursodiol Capsules, USP is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol, USP is ursodeoxycholic acid, a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 6Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 29
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,184 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Cftr gene mutation | 19 | 4,064.9 1,517.9–10,885.6ROR 4,068.9 · χ² 15,246 / p <1e-300 | 456.4 EB05 308.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial arm names this drug |
| Cytomegalovirus urinary tract infection | 13 | 772.6 378.6–1,576.5ROR 773.1 · χ² 5,377 / p <1e-300 | 270.6 EB05 168.3 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial arm names this drug |
| Tonic posturing | 14 | 332.8 182.7–606.2ROR 333.0 · χ² 3,284 / p <1e-300 | 189.0 EB05 119.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Bile acids increased | 35 | 301.9 207.5–439.3ROR 302.5 · χ² 7,954 / p <1e-300 | 208.9 EB05 157.0 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | no trial arm names this drug |
| Respiratory tract malformation | 28 | 296.6 195.2–450.6ROR 297.0 · χ² 6,228 / p <1e-300 | 200.7 EB05 145.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Philadelphia positive chronic myeloid leukaemia | 15 | 208.4 119.9–362.3ROR 208.5 · χ² 2,420 / p <1e-300 | 143.2 EB05 92.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial arm names this drug |
| Pulmonary malformation | 42 | 145.9 105.7–201.3ROR 146.2 · χ² 5,191 / p <1e-300 | 121.5 EB05 93.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 100% (drug 58%) · 90% clinician | no trial arm names this drug |
| Biliary cirrhosis | 21 | 124.8 79.4–196.1ROR 124.9 · χ² 2,200 / p <1e-300 | 101.8 EB05 70.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial arm names this drug |
| Haemosiderosis | 24 | 106.1 69.8–161.3ROR 106.2 · χ² 2,178 / p <1e-300 | 89.9 EB05 63.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | no trial arm names this drug |
| Blood alkaline phosphatase abnormal | 77 | 101.9 80.7–128.7ROR 102.3 · χ² 6,935 / p <1e-300 | 91.1 EB05 75.3 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=62 · ♀ 91% (drug 58%) | no trial arm names this drug |
| Varicella virus test positive | 13 | 88.6 50.3–155.9ROR 88.6 · χ² 960 / p 4e-211 | 73.4 EB05 45.6 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial arm names this drug |
| Cholestasis of pregnancy | 34 | 87.2 61.5–123.7ROR 87.4 · χ² 2,600 / p <1e-300 | 77.3 EB05 57.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Venoocclusive disease | 182 | 84.9 73.1–98.7ROR 85.7 · χ² 13,911 / p <1e-300 | 78.1 EB05 69.1 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=181 · ♀ 29% (drug 58%) · 97% clinician | no trial arm names this drug |
| Primary biliary cholangitis | 33 | 83.5 58.6–118.9ROR 83.6 · χ² 2,418 / p <1e-300 | 74.3 EB05 55.3 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=31 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Lung cyst | 27 | 80.0 54.1–118.3ROR 80.1 · χ² 1,887 / p <1e-300 | 70.9 EB05 51.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 100% (drug 58%) · 100% clinician | no trial arm names this drug |
| Parenteral nutrition | 15 | 75.3 44.6–127.1ROR 75.4 · χ² 959 / p 6e-211 | 64.9 EB05 41.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial arm names this drug |
| Venoocclusive liver disease | 270 | 63.0 55.8–71.2ROR 63.9 · χ² 15,505 / p <1e-300 | 59.3 EB05 53.6 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=270 · ♀ 36% (drug 58%) · 97% clinician | no trial arm names this drug |
| Biliary cirrhosis primary | 18 | 58.9 36.6–94.6ROR 58.9 · χ² 917 / p 1e-201 | 52.9 EB05 35.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial arm names this drug |
| Device related bacteraemia | 15 | 56.9 33.9–95.6ROR 56.9 · χ² 730 / p 5e-161 | 50.8 EB05 32.7 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=15 | no trial arm names this drug |
| Cystic fibrosis respiratory infection suppression | 42 | 53.1 39.0–72.4ROR 53.2 · χ² 1,996 / p <1e-300 | 49.6 EB05 38.2 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=42 · 79% consumer | no trial arm names this drug |
| Lactation disorder | 22 | 51.2 33.4–78.5ROR 51.2 · χ² 985 / p 1e-216 | 47.0 EB05 32.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial arm names this drug |
| Vanishing bile duct syndrome | 50 | 51.1 38.5–67.9ROR 51.3 · χ² 2,298 / p <1e-300 | 48.0 EB05 37.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 35% (drug 58%) · 100% clinician | no trial arm names this drug |
| Cholangitis sclerosing | 91 | 50.0 40.6–61.7ROR 50.3 · χ² 4,132 / p <1e-300 | 47.4 EB05 39.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=90 | no trial arm names this drug |
| Infective pulmonary exacerbation of cystic fibrosis | 236 | 48.8 42.8–55.5ROR 49.4 · χ² 10,517 / p <1e-300 | 46.5 EB05 41.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=213 | no trial arm names this drug |
| Aplastic anaemia | 225 | 48.6 42.6–55.5ROR 49.2 · χ² 9,996 / p <1e-300 | 46.4 EB05 41.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=225 · 100% clinician | no trial arm names this drug |
| Poor sucking reflex | 17 | 47.9 29.4–77.8ROR 47.9 · χ² 702 / p 5e-155 | 43.8 EB05 28.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial arm names this drug |
| Portal hypertensive gastropathy | 23 | 46.8 30.8–71.0ROR 46.8 · χ² 944 / p 2e-207 | 43.4 EB05 30.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial arm names this drug |
| Gamma-glutamyltransferase abnormal | 24 | 45.6 30.3–68.6ROR 45.7 · χ² 962 / p 2e-211 | 42.4 EB05 30.0 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=23 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Complications of transplanted liver | 14 | 43.3 25.4–73.8ROR 43.3 · χ² 516 / p 2e-114 | 39.6 EB05 25.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Disseminated aspergillosis | 18 | 43.3 27.0–69.3ROR 43.3 · χ² 674 / p 6e-149 | 40.0 EB05 26.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial arm names this drug |
| Biliary tract infection | 22 | 40.5 26.5–62.0ROR 40.6 · χ² 779 / p 9e-172 | 37.9 EB05 26.4 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=21 | no trial arm names this drug |
| Red blood cell transfusion | 14 | 39.3 23.1–67.0ROR 39.3 · χ² 468 / p 5e-104 | 36.2 EB05 22.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Bile duct stenosis | 41 | 38.3 28.0–52.2ROR 38.4 · χ² 1,401 / p <1e-300 | 36.4 EB05 28.0 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=41 | no trial arm names this drug |
| Aspartate aminotransferase abnormal | 47 | 34.8 26.0–46.5ROR 34.9 · χ² 1,463 / p <1e-300 | 33.3 EB05 26.1 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=45 · ♀ 86% (drug 58%) | no trial arm names this drug |
| Acute graft versus host disease in skin | 76 | 30.7 24.5–38.5ROR 30.8 · χ² 2,094 / p <1e-300 | 29.7 EB05 24.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=76 · ♀ 33% (drug 58%) · 100% clinician | no trial arm names this drug |
| Enterococcal sepsis | 22 | 30.0 19.7–45.8ROR 30.1 · χ² 572 / p 9e-127 | 28.6 EB05 19.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% clinician | no trial arm names this drug |
| Lip pruritus | 22 | 29.2 19.1–44.6ROR 29.2 · χ² 556 / p 3e-123 | 27.8 EB05 19.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | no trial arm names this drug |
| Hypertonia neonatal | 14 | 29.2 17.2–49.6ROR 29.2 · χ² 344 / p 4e-77 | 27.5 EB05 17.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Cystic fibrosis | 145 | 29.0 24.6–34.2ROR 29.2 · χ² 3,792 / p <1e-300 | 28.2 EB05 24.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=141 | no trial arm names this drug |
| Renal ischaemia | 14 | 28.7 16.9–48.8ROR 28.7 · χ² 338 / p 9e-76 | 27.0 EB05 17.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Ursosiol (searched URSOSIOL).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 1,748 | 2.2 2.1–2.3ROR 2.3 · χ² 1,172 / p 3e-257 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 | no trial arm names this drug |
| Pruritus (itching) | 1,256 | 3.6 3.4–3.8ROR 3.8 · χ² 2,408 / p <1e-300 | 3.6 EB05 3.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · ♀ 79% (drug 58%) | no trial arm names this drug |
| Diarrhoea (diarrhea) | 1,068 | 1.8 1.7–1.9ROR 1.8 · χ² 393 / p 1e-87 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial arm names this drug |
| Fatigue (tiredness) | 1,059 | 1.5 1.4–1.6ROR 1.5 · χ² 170 / p 3e-39 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial arm names this drug |
| Nausea | 972 | 1.3 1.3–1.4ROR 1.4 · χ² 85 / p 1e-20 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 921 | 0.8 0.7–0.8ROR 0.7 · χ² 75 / p 2e-18 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.2 | no trial arm names this drug |
| Pyrexia (fever) | 821 | 2.6 2.4–2.8ROR 2.6 · χ² 802 / p 1e-176 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | no trial arm names this drug |
| Pneumonia (lung infection) | 698 | 2.3 2.2–2.5ROR 2.4 · χ² 545 / p 8e-121 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.8 | no trial arm names this drug |
| Death | 692 | 0.9 0.8–0.9ROR 0.9 · χ² 13 / p 1e-4 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.6 | no trial arm names this drug |
| Vomiting | 634 | 1.5 1.4–1.6ROR 1.5 · χ² 96 / p 5e-23 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial arm names this drug |
| Headache | 594 | 1.0 1.0–1.1ROR 1.0 · χ² 0 / p 0.243 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 556 | 1.1 1.0–1.2ROR 1.1 · χ² 2 / p 0.064 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.9 | no trial arm names this drug |
| Abdominal pain | 516 | 2.4 2.2–2.6ROR 2.5 · χ² 429 / p 2e-95 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | no trial arm names this drug |
| Asthenia (weakness) | 483 | 1.4 1.3–1.5ROR 1.4 · χ² 54 / p 8e-14 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.3 | no trial arm names this drug |
| Dizziness | 462 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.450 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.8 | no trial arm names this drug |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Respiratory tract malformation — n=28, PRR 296.6
- Pulmonary malformation — n=42, PRR 145.9
- Biliary cirrhosis — n=21, PRR 124.8
- Haemosiderosis — n=24, PRR 106.1
- Cholestasis of pregnancy — n=34, PRR 87.2
- Venoocclusive disease — n=182, PRR 84.9
- Lung cyst — n=27, PRR 80.0
- Venoocclusive liver disease — n=270, PRR 63.0
- Lactation disorder — n=22, PRR 51.2
- Vanishing bile duct syndrome — n=50, PRR 51.1
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ursosiol?
In FDA FAERS, the most frequently co-reported reaction terms for Ursosiol are pruritus, diarrhoea, fatigue, nausea, pyrexia, pneumonia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ursosiol have an FDA boxed warning?
No. The FDA label retrieved for Ursosiol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ursosiol causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID d89c9e1e-a115-4a01-9275-74d6cd8cf285, effective 20250717; matched on
openfda.generic_name.exact:"URSOSIOL") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,224 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
URSOSIOL, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.