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FDA label 25792c1c-7cac-4470-a3a4-0accec70fa75

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)

SPL set ID
27238e3b-937e-4d18-85b7-0f69bc9e8761
SPL ID
25792c1c-7cac-4470-a3a4-0accec70fa75
Version
5
Effective date
2025-12-29
Source export date
2026-10-12
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/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:57:34

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) Post-marketing Experience The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post-approval use of ursodiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disorders : enteroliths (bezoars) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

adverse reactions table

<table cellpadding="0pt" cellspacing="0pt" width="100%"><col width="21%"/><col width="8%"/><col width="11%"/><col width="29%"/><col width="29%"/><thead><tr><th align="left" rowspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"/><th align="left" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Ursodiol 8 mg/kg/day to 10 mg/kg/day(N = 155)</content></th><th align="left" colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Placebo(N = 159)</content></th></tr><tr><th align="left" styleCode="Rrule Lrule Toprule Botrule " valign="top"><content styleCode="bold">N</content></th><th align="left" styleCode="Rrule Lrule Toprule Botrule " valign="top"><content styleCode="bold">(%)</content></th><th align="left" styleCode="Rrule Lrule Toprule Botrule " valign="top"><content styleCode="bold">N</content></th><th align="left" styleCode="Rrule Lrule Toprule Botrule " valign="top"><content styleCode="bold">(%)</content></th></tr></thead><tbody><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Body as a Whole</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Allergy</paragraph><paragraph>Chest Pain</paragraph><paragraph>Fatigue</paragraph><paragraph>Infection Viral</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>8 </paragraph><paragraph>5 </paragraph><paragraph>7 </paragraph><paragraph>30 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(5.2)</paragraph><paragraph>(3.2)</paragraph><paragraph>(4.5)</paragraph><paragraph>(19.4)</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>7 </paragraph><paragraph>10 </paragraph><paragraph>8 </paragraph><paragraph>41 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(4.4)</paragraph><paragraph>(6.3)</paragraph><paragraph>(5.0)</paragraph><paragraph>(25.8)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Digestive System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><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="Rrule Lrule Toprule Botrule " valign="top"><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="Rrule Lrule Toprule Botrule " valign="top"><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="Rrule Lrule Toprule Botrule " valign="top"><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="Rrule Lrule Toprule Botrule " valign="top"><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="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Musculoskeletal System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Arthralgia</paragraph><paragraph>Arthritis</paragraph><paragraph>Back Pain</paragraph><paragraph>Myalgia</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>12 </paragraph><paragraph>9 </paragraph><paragraph>11 </paragraph><paragraph>9 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(7.7)</paragraph><paragraph>(5.8)</paragraph><paragraph>(7.1)</paragraph><paragraph>(5.8)</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>24 </paragraph><paragraph>4 </paragraph><paragraph>18 </paragraph><paragraph>9 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(15.1)</paragraph><paragraph>(2.5)</paragraph><paragraph>(11.3)</paragraph><paragraph>(5.7)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Nervous System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Headache</paragraph><paragraph>Insomnia</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>28 </paragraph><paragraph> 3 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(18.1)</paragraph><paragraph>(1.9)</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>34 </paragraph><paragraph>8 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(21.4)</paragraph><paragraph>(5.0)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Respiratory System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Bronchitis</paragraph><paragraph>Coughing</paragraph><paragraph>Pharyngitis</paragraph><paragraph>Rhinitis</paragraph><paragraph>Sinusitis</paragraph><paragraph>Upper Respiratory Tract Infection</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>10 </paragraph><paragraph>11 </paragraph><paragraph>13 </paragraph><paragraph>8 </paragraph><paragraph>17 </paragraph><paragraph>24 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><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="Rrule Lrule Toprule Botrule " valign="top"><paragraph>6 </paragraph><paragraph>7 </paragraph><paragraph>5 </paragraph><paragraph>11 </paragraph><paragraph>18 </paragraph><paragraph>21 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><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="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Urogenital System</content></paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>Urinary Tract Infection</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>10 </paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>(6.5)</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>7 </paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>(4.4)</paragraph></td></tr></tbody></table>

adverse reactions table

<table cellpadding="0pt" cellspacing="0pt" width="100%"><col width="24%"/><col width="4%"/><col width="9%"/><col width="30%"/><col width="30%"/><tbody><tr><td rowspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"/><td colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold"><content styleCode="underline">Ursodiol</content></content></paragraph><paragraph>600 mg</paragraph><paragraph>(N = 322)</paragraph></td><td colspan="2" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold"><content styleCode="underline">Placebo</content></content></paragraph><paragraph>(N = 325)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>N</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(%)</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>N</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(%)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Body as a Whole</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Fatigue</paragraph><paragraph>Infection Viral</paragraph><paragraph>Influenza-like Symptoms</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>25 </paragraph><paragraph>29 </paragraph><paragraph>21 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(7.8)</paragraph><paragraph>(9.0)</paragraph><paragraph>(6.5)</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>33 </paragraph><paragraph>29 </paragraph><paragraph>19 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(10.2)</paragraph><paragraph>(8.9)</paragraph><paragraph>(5.8)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Digestive System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Abdominal Pain</paragraph><paragraph>Constipation</paragraph><paragraph>Diarrhea</paragraph><paragraph>Flatulence</paragraph><paragraph>Nausea</paragraph><paragraph>Vomiting</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>20 </paragraph><paragraph>85 </paragraph><paragraph>81 </paragraph><paragraph>15 </paragraph><paragraph>56 </paragraph><paragraph>44 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><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="Rrule Lrule Toprule Botrule " valign="top"><paragraph>39 </paragraph><paragraph>72 </paragraph><paragraph>68 </paragraph><paragraph>24 </paragraph><paragraph>43 </paragraph><paragraph>44 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><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="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Musculoskeletal System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Back Pain</paragraph><paragraph>Musculoskeletal Pain</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>38 </paragraph><paragraph>19 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(11.8)</paragraph><paragraph>(5.9)</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>21 </paragraph><paragraph>15 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(6.5)</paragraph><paragraph>(4.6)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Nervous System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Dizziness</paragraph><paragraph>Headache</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>53 </paragraph><paragraph>80 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(16.5)</paragraph><paragraph>(24.8)</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>42 </paragraph><paragraph>78 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(12.9)</paragraph><paragraph>(24.0)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Respiratory System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Pharyngitis</paragraph><paragraph>Sinusitis</paragraph><paragraph>Upper Respiratory Tract Infection</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>10 </paragraph><paragraph>17 </paragraph><paragraph>40 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(3.1)</paragraph><paragraph>(5.3)</paragraph><paragraph>(12.4)</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>19 </paragraph><paragraph>18 </paragraph><paragraph>35 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(5.8)</paragraph><paragraph>(5.5)</paragraph><paragraph>(10.8)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Skin and Appendages</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Alopecia</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>17 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(5.3)</paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>8 </paragraph></td><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>(2.5)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">Urogenital System</content></paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>Dysmenorrhea</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>18 </paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>(5.6)</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>19 </paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>(5.8)</paragraph></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.