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
- AvPAK
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- bbb1f297-1536-9550-e053-2995a90a0d41
- SPL ID
- 48378beb-66aa-975e-e063-6294a90a0aee
- Version
- 4
- Effective date
- 2026-01-12
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:49:00
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 · 14 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 8 mg/kg/day to 10 mg/kg/day (N = 155) Placebo (N = 159) N (%) N (%) Body as a Whole Allergy Chest Pain Fatigue Infection Viral 8 5 7 30 (5.2) (3.2) (4.5) (19.4) 7 10 8 41 (4.4) (6.3) (5.0) (25.8) Digestive System Abdominal Pain Cholecystitis Constipation Diarrhea Dyspepsia Flatulence Gastrointestinal Disorder Nausea Vomiting 67 8 15 42 26 12 6 22 15 (43.2) (5.2) (9.7) (27.1) (16.8) (7.7) (3.9) (14.2) (9.7) 70 7 14 34 18 12 8 27 11 (44.0) (4.4) (8.8) (21.4) (11.3) (7.5) (5.0) (17.0) (6.9) Musculoskeletal System Arthralgia Arthritis Back Pain Myalgia 12 9 11 9 (7.7) (5.8) (7.1) (5.8) 24 4 18 9 (15.1) (2.5) (11.3) (5.7) Nervous System Headache Insomnia 28 3 (18.1) (1.9) 34 8 (21.4) (5.0) Respiratory System Bronchitis Coughing Pharyngitis Rhinitis Sinusitis Upper Respiratory Tract Infection 10 11 13 8 17 24 (6.5) (7.1) (8.4) (5.2) (11.0) (15.5) 6 7 5 11 18 21 (3.8) (4.4) (3.1) (6.9) (11.3) (13.2) Urogenital System Urinary Tract Infection 10 (6.5) 7 (4.4) GALLSTONE PREVENTION Ursodiol, 600 mg (N = 322) Placebo (N = 325) N (%) N (%) Body as a Whole Fatigue Infection Viral Influenza-like Symptoms 25 29 21 (7.8) (9.0) (6.5) 33 29 19 (10.2) (8.9) (5.8) Digestive System Abdominal Pain Constipation Diarrhea Flatulence Nausea Vomiting 20 85 81 15 56 44 (6.2) (26.4) (25.2) (4.7) (17.4) (13.7) 39 72 68 24 43 44 (12.0) (22.2) (20.9) (7.4) (13.2) (13.5) Musculoskeletal System Back Pain Musculoskeletal Pain 38 19 (11.8) (5.9) 21 15 (6.5) (4.6) Nervous System Dizziness Headache 53 80 (16.5) (24.8) 42 78 (12.9) (24.0) Respiratory System Pharyngitis Sinusitis Upper Respiratory Tract Infection 10 17 40 (3.1) (5.3) (12.4) 19 18 35 (5.8) (5.5) (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 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
adverse reactions table
<table border="1" cellpadding="0" cellspacing="0" width="100%"><colgroup><col width="35.16px"/><col width="35.16px"/><col width="35.16px"/><col width="35.16px"/><col width="35.16px"/></colgroup><thead><tr><td rowspan="2" styleCode="Botrule Toprule Lrule Rrule "/><td colspan="2" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Ursodiol</content></paragraph><paragraph>8 mg/kg/day to 10 mg/kg/day</paragraph><paragraph>(N = 155)</paragraph></td><td colspan="2" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Placebo</content></paragraph><paragraph>(N = 159)</paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>N</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(%)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>N</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(%)</paragraph></td></tr></thead><tbody><tr><td colspan="5" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Body as a Whole</content></paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>Allergy</paragraph><paragraph>Chest Pain</paragraph><paragraph>Fatigue</paragraph><paragraph>Infection Viral</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>8</paragraph><paragraph>5</paragraph><paragraph>7</paragraph><paragraph>30</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(5.2)</paragraph><paragraph>(3.2)</paragraph><paragraph>(4.5)</paragraph><paragraph>(19.4)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>7</paragraph><paragraph>10</paragraph><paragraph>8</paragraph><paragraph>41</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(4.4)</paragraph><paragraph>(6.3)</paragraph><paragraph>(5.0)</paragraph><paragraph>(25.8)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Digestive System</content></paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>Abdominal Pain</paragraph><paragraph>Cholecystitis</paragraph><paragraph>Constipation</paragraph><paragraph>Diarrhea</paragraph><paragraph>Dyspepsia</paragraph><paragraph>Flatulence</paragraph><paragraph>Gastrointestinal Disorder</paragraph><paragraph>Nausea</paragraph><paragraph>Vomiting</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>67</paragraph><paragraph>8</paragraph><paragraph>15</paragraph><paragraph>42</paragraph><paragraph>26</paragraph><paragraph>12</paragraph><paragraph>6</paragraph><paragraph>22</paragraph><paragraph>15</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(43.2)</paragraph><paragraph>(5.2)</paragraph><paragraph>(9.7)</paragraph><paragraph>(27.1)</paragraph><paragraph>(16.8)</paragraph><paragraph>(7.7)</paragraph><paragraph>(3.9)</paragraph><paragraph>(14.2)</paragraph><paragraph>(9.7)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>70</paragraph><paragraph>7</paragraph><paragraph>14</paragraph><paragraph>34</paragraph><paragraph>18</paragraph><paragraph>12</paragraph><paragraph>8</paragraph><paragraph>27</paragraph><paragraph>11</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(44.0)</paragraph><paragraph>(4.4)</paragraph><paragraph>(8.8)</paragraph><paragraph>(21.4)</paragraph><paragraph>(11.3)</paragraph><paragraph>(7.5)</paragraph><paragraph>(5.0)</paragraph><paragraph>(17.0)</paragraph><paragraph>(6.9)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Musculoskeletal System</content></paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>Arthralgia</paragraph><paragraph>Arthritis</paragraph><paragraph>Back Pain</paragraph><paragraph>Myalgia</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>12</paragraph><paragraph>9</paragraph><paragraph>11</paragraph><paragraph>9</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(7.7)</paragraph><paragraph>(5.8)</paragraph><paragraph>(7.1)</paragraph><paragraph>(5.8)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>24</paragraph><paragraph>4</paragraph><paragraph>18</paragraph><paragraph>9</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(15.1)</paragraph><paragraph>(2.5)</paragraph><paragraph>(11.3)</paragraph><paragraph>(5.7)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Nervous System</content></paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>Headache</paragraph><paragraph>Insomnia</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>28</paragraph><paragraph>3</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(18.1)</paragraph><paragraph>(1.9)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>34</paragraph><paragraph>8</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(21.4)</paragraph><paragraph>(5.0)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Respiratory System</content></paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>Bronchitis</paragraph><paragraph>Coughing</paragraph><paragraph>Pharyngitis</paragraph><paragraph>Rhinitis</paragraph><paragraph>Sinusitis</paragraph><paragraph>Upper Respiratory Tract Infection</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>10</paragraph><paragraph>11</paragraph><paragraph>13</paragraph><paragraph>8</paragraph><paragraph>17</paragraph><paragraph>24</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(6.5)</paragraph><paragraph>(7.1)</paragraph><paragraph>(8.4)</paragraph><paragraph>(5.2)</paragraph><paragraph>(11.0)</paragraph><paragraph>(15.5)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>6</paragraph><paragraph>7</paragraph><paragraph>5</paragraph><paragraph>11</paragraph><paragraph>18</paragraph><paragraph>21</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(3.8)</paragraph><paragraph>(4.4)</paragraph><paragraph>(3.1)</paragraph><paragraph>(6.9)</paragraph><paragraph>(11.3)</paragraph><paragraph>(13.2)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Urogenital System</content></paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>Urinary Tract Infection</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>10</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(6.5)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>7</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(4.4)</paragraph></td></tr></tbody></table>
adverse reactions table
<table border="1" cellpadding="0" cellspacing="0" width="100%"><colgroup><col width="17px"/><col width="17px"/><col width="17px"/><col width="17px"/><col width="17px"/></colgroup><tbody><tr><td rowspan="2" styleCode="Botrule Toprule Lrule Rrule "/><td colspan="2" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold"><content styleCode="underline">Ursodiol, </content></content></paragraph><paragraph>600 mg</paragraph><paragraph>(N = 322)</paragraph></td><td colspan="2" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold"><content styleCode="underline">Placebo</content></content></paragraph><paragraph>(N = 325)</paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>N</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(%)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>N</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(%)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Body as a Whole</content></paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>Fatigue</paragraph><paragraph>Infection Viral</paragraph><paragraph>Influenza-like Symptoms</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>25</paragraph><paragraph>29</paragraph><paragraph>21</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(7.8)</paragraph><paragraph>(9.0)</paragraph><paragraph>(6.5)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>33</paragraph><paragraph>29</paragraph><paragraph>19</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(10.2)</paragraph><paragraph>(8.9)</paragraph><paragraph>(5.8)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Digestive System</content></paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>Abdominal Pain</paragraph><paragraph>Constipation</paragraph><paragraph>Diarrhea</paragraph><paragraph>Flatulence</paragraph><paragraph>Nausea</paragraph><paragraph>Vomiting</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>20</paragraph><paragraph>85</paragraph><paragraph>81</paragraph><paragraph>15</paragraph><paragraph>56</paragraph><paragraph>44</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(6.2)</paragraph><paragraph>(26.4)</paragraph><paragraph>(25.2)</paragraph><paragraph>(4.7)</paragraph><paragraph>(17.4)</paragraph><paragraph>(13.7)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>39</paragraph><paragraph>72</paragraph><paragraph>68</paragraph><paragraph>24</paragraph><paragraph>43</paragraph><paragraph>44</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(12.0)</paragraph><paragraph>(22.2)</paragraph><paragraph>(20.9)</paragraph><paragraph>(7.4)</paragraph><paragraph>(13.2)</paragraph><paragraph>(13.5)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Musculoskeletal System</content></paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>Back Pain</paragraph><paragraph>Musculoskeletal Pain</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>38</paragraph><paragraph>19</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(11.8)</paragraph><paragraph>(5.9)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>21</paragraph><paragraph>15</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(6.5)</paragraph><paragraph>(4.6)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Nervous System</content></paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>Dizziness</paragraph><paragraph>Headache</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>53</paragraph><paragraph>80</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(16.5)</paragraph><paragraph>(24.8)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>42</paragraph><paragraph>78</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(12.9)</paragraph><paragraph>(24.0)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Respiratory System</content></paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>Pharyngitis</paragraph><paragraph>Sinusitis</paragraph><paragraph>Upper Respiratory Tract Infection</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>10</paragraph><paragraph>17</paragraph><paragraph>40</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(3.1)</paragraph><paragraph>(5.3)</paragraph><paragraph>(12.4)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>19</paragraph><paragraph>18</paragraph><paragraph>35</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(5.8)</paragraph><paragraph>(5.5)</paragraph><paragraph>(10.8)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Skin and Appendages</content></paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>Alopecia</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>17</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(5.3)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>8</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(2.5)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Toprule Lrule Rrule "><paragraph><content styleCode="bold">Urogenital System</content></paragraph></td></tr><tr><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>Dysmenorrhea</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>18</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(5.6)</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>19</paragraph></td><td styleCode="Botrule Toprule Lrule Rrule "><paragraph>(5.8)</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.