Ursodiol
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
- Brand name
- Ursodiol
- Generic name
- URSODIOL
- Manufacturer
- AvKARE
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 00c47258-aef0-53f6-e063-6294a90af96f
- SPL ID
- 48bfa576-f7b2-85ff-e063-6394a90a0504
- Version
- 2
- Effective date
- 2026-01-19
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:38:57
Harmonized routes table| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 12 matching rows.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 3 matching rows.
adverse reactions
ADVERSE REACTIONS The nature and frequency of adverse experiences were similar across all groups. The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level: GALLSTONE DISSOLUTION Ursodiol Placebo 8 - 10 mg/kg/day (N = 155) (N = 159) N (%) N (%) Body as a Whole Allergy 8 (5.2) 7 (4.4) Chest Pain 5 (3.2) 10 (6.3) Fatigue 7 (4.5) 8 (5.0) Infection Viral 30 (19.4) 41 (25.8) Digestive System Abdominal Pain 67 (43.2) 70 (44.0) Cholecystitis 8 (5.2) 7 (4.4) Constipation 15 (9.7) 14 (8.8) Diarrhea 42 (27.1) 34 (21.4) Dyspepsia 26 (16.8) 18 (11.3) Flatulence 12 (7.7) 12 (7.5) Gastrointestinal Disorder 6 (3.9) 8 (5.0) Nausea 22 (14.2) 27 (17.0) Vomiting 15 (9.7) 11 (6.9) Musculoskeletal System Arthralgia 12 (7.7) 24 (15.1) Arthritis 9 (5.8) 4 (2.5) Back Pain 11 (7.1) 18 (11.3) Myalgia 9 (5.8) 9 (5.7) Nervous System Headache 28 (18.1) 34 (21.4) Insomnia 3 (1.9) 8 (5.0) Respiratory System Bronchitis 10 (6.5) 6 (3.8) Coughing 11 (7.1) 7 (4.4) Pharyngitis 13 (8.4) 5 (3.1) Rhinitis 8 (5.2) 11 (6.9) Sinusitis 17 (11.0) 18 (11.3) Upper Respiratory Tract Infection 24 (15.5) 21 (13.2) Urogenital System Urinary Tract Infection 10 (6.5) 7 (4.4) GALLSTONE PREVENTION Ursodiol Placebo 600 mg (N = 322) (N = 325) N (%) N (%) Body as a Whole Fatigue 25 (7.8) 33 (10.2) Infection Viral 29 (9.0) 29 (8.9) Influenza-like Symptoms 21 (6.5) 19 (5.8) Digestive System Abdominal Pain 20 (6.2) 39 (12.0) Constipation 85 (26.4) 72 (22.2) Diarrhea 81 (25.2) 68 (20.9) Flatulence 15 (4.7) 24 (7.4) Nausea 56 (17.4) 43 (13.2) Vomiting 44 (13.7) 44 (13.5) Musculoskeletal System Back Pain 38 (11.8) 21 (6.5) Musculoskeletal Pain 19 (5.9) 15 (4.6) Nervous System Dizziness 53 (16.5) 42 (12.9) Headache 80 (24.8) 78 (24.0) Respiratory System Pharyngitis 10 (3.1) 19 (5.8) Sinusitis 17 (5.3) 18 (5.5) Upper Respiratory Tract Infection 40 (12.4) 35 (10.8) Skin and Appendages Alopecia 17 (5.3) 8 (2.5) Urogenital System Dysmenorrhea 18 (5.6) 19 (5.8) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
adverse reactions table
<table><caption>GALLSTONE DISSOLUTION</caption><colgroup><col/><col/><col/><col/><col/></colgroup><tbody><tr><td/><td align="center" colspan="2"><content styleCode="bold"><content styleCode="underline">Ursodiol</content></content></td><td align="center" colspan="2"><content styleCode="bold"><content styleCode="underline">Placebo</content></content></td></tr><tr><td/><td align="center" colspan="2"> 8 - 10 mg/kg/day</td><td align="center" colspan="2"/></tr><tr><td/><td align="center" colspan="2"> (N = 155)</td><td align="center" colspan="2"> (N = 159)</td></tr><tr><td/><td align="center"><content styleCode="underline">N</content></td><td align="center"><content styleCode="underline">(%)</content></td><td align="center"><content styleCode="underline">N</content></td><td align="center"><content styleCode="underline">(%)</content></td></tr><tr><td><content styleCode="bold"><content styleCode="underline">Body as a Whole</content></content></td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Allergy</td><td align="center">8</td><td align="center">(5.2)</td><td align="center">7</td><td align="center">(4.4)</td></tr><tr><td> Chest Pain</td><td align="center">5</td><td align="center">(3.2)</td><td align="center">10</td><td align="center">(6.3)</td></tr><tr><td> Fatigue</td><td align="center">7</td><td align="center">(4.5)</td><td align="center">8</td><td align="center">(5.0)</td></tr><tr><td> Infection Viral</td><td align="center">30</td><td align="center">(19.4)</td><td align="center">41</td><td align="center">(25.8)</td></tr><tr><td><content styleCode="bold"><content styleCode="underline">Digestive System</content></content></td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Abdominal Pain</td><td align="center">67</td><td align="center">(43.2)</td><td align="center">70</td><td align="center">(44.0)</td></tr><tr><td> Cholecystitis</td><td align="center">8</td><td align="center">(5.2)</td><td align="center">7</td><td align="center">(4.4)</td></tr><tr><td> Constipation</td><td align="center">15</td><td align="center">(9.7)</td><td align="center">14</td><td align="center">(8.8)</td></tr><tr><td> Diarrhea</td><td align="center">42</td><td align="center">(27.1)</td><td align="center">34</td><td align="center">(21.4)</td></tr><tr><td> Dyspepsia</td><td align="center">26</td><td align="center">(16.8)</td><td align="center">18</td><td align="center">(11.3)</td></tr><tr><td> Flatulence</td><td align="center">12</td><td align="center">(7.7)</td><td align="center">12</td><td align="center">(7.5)</td></tr><tr><td> Gastrointestinal Disorder</td><td align="center">6</td><td align="center">(3.9)</td><td align="center">8</td><td align="center">(5.0)</td></tr><tr><td> Nausea</td><td align="center">22</td><td align="center">(14.2)</td><td align="center">27</td><td align="center">(17.0)</td></tr><tr><td> Vomiting</td><td align="center">15</td><td align="center">(9.7)</td><td align="center">11</td><td align="center">(6.9)</td></tr><tr><td><content styleCode="bold"><content styleCode="underline">Musculoskeletal System</content></content></td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Arthralgia</td><td align="center">12</td><td align="center">(7.7)</td><td align="center">24</td><td align="center">(15.1)</td></tr><tr><td> Arthritis</td><td align="center">9</td><td align="center">(5.8)</td><td align="center">4</td><td align="center">(2.5)</td></tr><tr><td> Back Pain</td><td align="center">11</td><td align="center">(7.1)</td><td align="center">18</td><td align="center">(11.3)</td></tr><tr><td> Myalgia</td><td align="center">9</td><td align="center">(5.8)</td><td align="center">9</td><td align="center">(5.7)</td></tr><tr><td><content styleCode="bold"><content styleCode="underline">Nervous System</content></content></td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Headache</td><td align="center">28</td><td align="center">(18.1)</td><td align="center">34</td><td align="center">(21.4)</td></tr><tr><td> Insomnia</td><td align="center">3</td><td align="center">(1.9)</td><td align="center">8</td><td align="center">(5.0)</td></tr><tr><td><content styleCode="bold"><content styleCode="underline">Respiratory System</content></content></td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Bronchitis</td><td align="center">10</td><td align="center">(6.5)</td><td align="center">6</td><td align="center">(3.8)</td></tr><tr><td> Coughing</td><td align="center">11</td><td align="center">(7.1)</td><td align="center">7</td><td align="center">(4.4)</td></tr><tr><td> Pharyngitis</td><td align="center">13</td><td align="center">(8.4)</td><td align="center">5</td><td align="center">(3.1)</td></tr><tr><td> Rhinitis</td><td align="center">8</td><td align="center">(5.2)</td><td align="center">11</td><td align="center">(6.9)</td></tr><tr><td> Sinusitis</td><td align="center">17</td><td align="center">(11.0)</td><td align="center">18</td><td align="center">(11.3)</td></tr><tr><td> Upper Respiratory</td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Tract Infection</td><td align="center">24</td><td align="center">(15.5)</td><td align="center">21</td><td align="center">(13.2)</td></tr><tr><td><content styleCode="bold"><content styleCode="underline">Urogenital System</content></content></td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Urinary Tract Infection</td><td align="center">10</td><td align="center">(6.5)</td><td align="center">7</td><td align="center">(4.4)</td></tr></tbody></table>
adverse reactions table
<table><caption>GALLSTONE PREVENTION</caption><colgroup><col/><col/><col/><col/><col/></colgroup><tbody><tr><td/><td align="center" colspan="2"><content styleCode="bold"><content styleCode="underline">Ursodiol</content></content></td><td align="center" colspan="2"><content styleCode="bold"><content styleCode="underline">Placebo</content></content></td></tr><tr><td/><td align="center" colspan="2"> 600 mg</td><td align="center" colspan="2"/></tr><tr><td/><td align="center" colspan="2"> (N = 322)</td><td align="center" colspan="2"> (N = 325)</td></tr><tr><td><content styleCode="underline"/></td><td align="center"><content styleCode="underline">N</content></td><td align="center"><content styleCode="underline">(%)</content></td><td align="center"><content styleCode="underline">N</content></td><td align="center"><content styleCode="underline">(%)</content></td></tr><tr><td><content styleCode="bold"><content styleCode="underline">Body as a Whole</content></content></td><td/><td/><td/><td/></tr><tr><td> Fatigue </td><td align="center">25</td><td align="center">(7.8)</td><td align="center">33</td><td align="center">(10.2)</td></tr><tr><td> Infection Viral</td><td align="center">29</td><td align="center">(9.0)</td><td align="center">29</td><td align="center">(8.9)</td></tr><tr><td> Influenza-like Symptoms</td><td align="center">21</td><td align="center">(6.5)</td><td align="center">19</td><td align="center">(5.8)</td></tr><tr><td><content styleCode="bold"><content styleCode="underline">Digestive System</content></content></td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Abdominal Pain</td><td align="center">20</td><td align="center">(6.2)</td><td align="center">39</td><td align="center">(12.0)</td></tr><tr><td> Constipation</td><td align="center">85</td><td align="center">(26.4)</td><td align="center">72</td><td align="center">(22.2)</td></tr><tr><td> Diarrhea</td><td align="center">81</td><td align="center">(25.2)</td><td align="center">68</td><td align="center">(20.9)</td></tr><tr><td> Flatulence</td><td align="center">15</td><td align="center">(4.7)</td><td align="center">24</td><td align="center">(7.4)</td></tr><tr><td> Nausea</td><td align="center">56</td><td align="center">(17.4)</td><td align="center">43</td><td align="center">(13.2)</td></tr><tr><td> Vomiting</td><td align="center">44</td><td align="center">(13.7)</td><td align="center">44</td><td align="center">(13.5)</td></tr><tr><td><content styleCode="bold"><content styleCode="underline">Musculoskeletal System</content></content></td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Back Pain</td><td align="center">38</td><td align="center">(11.8)</td><td align="center">21</td><td align="center">(6.5)</td></tr><tr><td> Musculoskeletal Pain</td><td align="center">19</td><td align="center">(5.9)</td><td align="center">15</td><td align="center">(4.6)</td></tr><tr><td><content styleCode="bold"><content styleCode="underline">Nervous System</content></content></td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Dizziness</td><td align="center">53</td><td align="center">(16.5)</td><td align="center">42</td><td align="center">(12.9)</td></tr><tr><td> Headache</td><td align="center">80</td><td align="center">(24.8)</td><td align="center">78</td><td align="center">(24.0)</td></tr><tr><td><content styleCode="bold"><content styleCode="underline">Respiratory System</content></content></td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Pharyngitis</td><td align="center">10</td><td align="center">(3.1)</td><td align="center">19</td><td align="center">(5.8)</td></tr><tr><td> Sinusitis</td><td align="center">17</td><td align="center">(5.3)</td><td align="center">18</td><td align="center">(5.5)</td></tr><tr><td> Upper Respiratory</td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Tract Infection</td><td align="center">40</td><td align="center">(12.4)</td><td align="center">35</td><td align="center">(10.8)</td></tr><tr><td><content styleCode="bold"><content styleCode="underline">Skin and Appendages</content></content></td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Alopecia</td><td align="center">17</td><td align="center">(5.3)</td><td align="center">8</td><td align="center">(2.5)</td></tr><tr><td><content styleCode="bold"><content styleCode="underline">Urogenital System</content></content></td><td align="center"/><td align="center"/><td align="center"/><td align="center"/></tr><tr><td> Dysmenorrhea</td><td align="center">18</td><td align="center">(5.6)</td><td align="center">19</td><td align="center">(5.8)</td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.