FDA label e82e19aa-d376-05b6-e053-2a95a90aa3f2
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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- SPL set ID
- 48e7e53f-3565-4c01-b1d3-81ebe1e7f2a6
- SPL ID
- e82e19aa-d376-05b6-e053-2a95a90aa3f2
- Version
- 5
- Effective date
- 2022-09-08
- 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 05:49:44
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 · 2 matching rows.
Adverse reactions cross-check#
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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 to 10 mg/kg/day Placebo (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) Infection Viral 30 (19.4) 41 (25.8) Digestive System Abdominal Pain 67 (43.2) 70 (44) 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) Nausea 22 (14.2) 27 (17) 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) 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) 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) 29 (8.9) Influenza-like Symptoms 21 (6.5) 19 (5.8) Digestive System Abdominal Pain 20 (6.2) 39 (12) 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) 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)
adverse reactions table
<table ID="_RefID0EIHAE" width="100%"><caption>GALLSTONE DISSOLUTION</caption><col width="31%"/><col width="26%"/><col width="15%"/><col width="14%"/><col width="15%"/><tbody><tr><td rowspan="3" styleCode="Rrule Botrule Lrule Toprule " valign="top"/><td align="center" colspan="2" styleCode="Rrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Ursodiol</content> 8 to 10 mg/kg/day </paragraph></td><td align="center" colspan="2" styleCode="Rrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Placebo</content> </paragraph></td></tr><tr><td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(N = 155)</paragraph></td><td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(N = 159)</paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>N</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>N</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(%)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Body as a Whole</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Allergy</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>7</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(4.4)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Chest Pain</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>5</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(3.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>10</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(6.3)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Fatigue</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>7</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(4.5)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Infection Viral</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>30</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(19.4)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>41</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(25.8)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Digestive System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Abdominal Pain</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>67</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(43.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>70</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(44)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Cholecystitis</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>7</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(4.4)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Constipation</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>15</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(9.7)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>14</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(8.8)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Diarrhea</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>42</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(27.1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>34</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(21.4)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Dyspepsia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>26</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(16.8)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(11.3)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Flatulence</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>12</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(7.7)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>12</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(7.5)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Gastrointestinal Disorder</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(3.9)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Nausea</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>22</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(14.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>27</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(17)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Vomiting</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>15</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(9.7)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>11</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(6.9)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Musculoskeletal System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Arthralgia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>12</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(7.7)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>24</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(15.1)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Arthritis</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>9</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5.8)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>4</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(2.5)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Back Pain</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>11</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(7.1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(11.3)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Myalgia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>9</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5.8)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>9</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5.7)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Nervous System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Headache</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>28</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(18.1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>34</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(21.4)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Insomnia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>3</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(1.9)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Respiratory System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Bronchitis</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>10</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(6.5)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>6</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(3.8)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Coughing</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>11</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(7.1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>7</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(4.4)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Pharyngitis</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>13</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(8.4)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>5</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(3.1)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Rhinitis</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>11</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(6.9)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Sinusitis</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>17</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(11)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(11.3)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Upper Respiratory Tract Infection</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>24</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>(15.5)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>21</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="middle"><paragraph>(13.2)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Urogenital System</content></paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph> Urinary Tract Infection</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>10</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>(6.5)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>7</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>(4.4)</paragraph></td></tr></tbody></table>
adverse reactions table
<table ID="_RefID0EM6AE" width="100%"><caption>GALLSTONE PREVENTION</caption><col width="35%"/><col width="30%"/><col width="12%"/><col width="11%"/><col width="12%"/><tbody><tr><td rowspan="4" styleCode="Rrule Botrule Lrule Toprule " valign="top"/><td align="center" colspan="2" styleCode="Rrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Ursodiol</content></paragraph></td><td align="center" colspan="2" styleCode="Rrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Placebo</content></paragraph></td></tr><tr><td align="center" colspan="2" valign="top"><paragraph>600 mg</paragraph></td><td colspan="2" styleCode="Rrule Lrule " valign="top"/></tr><tr><td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(N = 322)</paragraph></td><td align="center" colspan="2" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(N = 325)</paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>N</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>N</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(%)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Body as a Whole</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Fatigue</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>25</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(7.8)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>33</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(10.2)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Infection Viral</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>29</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(9)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>29</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(8.9)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Influenza-like Symptoms</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>21</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(6.5)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>19</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5.8)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Digestive System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Abdominal Pain</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>20</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(6.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>39</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(12)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Constipation</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>85</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(26.4)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>72</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(22.2)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Diarrhea</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>81</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(25.2)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>68</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(20.9)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Flatulence</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>15</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(4.7)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>24</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(7.4)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Nausea</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>56</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(17.4)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>43</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(13.2)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Vomiting</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>44</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(13.7)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>44</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(13.5)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Musculoskeletal System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Back Pain</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>38</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(11.8)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>21</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(6.5)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Musculoskeletal Pain</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>19</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5.9)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>15</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(4.6)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Nervous System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Dizziness</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>53</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(16.5)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>42</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(12.9)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Headache</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>80</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(24.8)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>78</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(24)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Respiratory System</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Pharyngitis</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>10</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(3.1)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>19</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5.8)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Sinusitis</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>17</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5.3)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5.5)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Upper Respiratory Tract Infection</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>40</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(12.4)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>35</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(10.8)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Skin and Appendages</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> Alopecia</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>17</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(5.3)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>(2.5)</paragraph></td></tr><tr><td colspan="5" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">Urogenital System</content></paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph> Dysmenorrhea</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>(5.6)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>19</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " 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.