FDA label 25663adc-777b-4368-a43c-e978b453e2d8

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)

<table width="90%"><caption>GALLSTONE DISSOLUTION</caption><col width="50%" align="left" valign="bottom"/><col width="12%" align="center" valign="bottom"/><col width="13%" align="center" valign="bottom"/><col width="12%" align="center" valign="bottom"/><col width="13%" align="center" valign="bottom"/><thead><tr><th/><th colspan="2"><content styleCode="underline">Ursodiol</content></th><th colspan="2"><content styleCode="underline">Placebo</content></th></tr><tr><th/><th colspan="2">8 - 10 mg/kg/day (N=155)</th><th colspan="2">(N=159)</th></tr><tr><th/><th>N</th><th>(%)</th><th>N</th><th>(%)</th></tr></thead><tbody><tr><td><content styleCode="bold underline">Body as a Whole</content></td><td/><td/><td/><td/></tr><tr><td> Allergy</td><td>8</td><td>(5.2)</td><td>7</td><td>(4.4)</td></tr><tr><td> Chest Pain</td><td>5</td><td>(3.2)</td><td>10</td><td>(6.3)</td></tr><tr><td> Fatigue</td><td>7</td><td>(4.5)</td><td>8</td><td>(5.0)</td></tr><tr><td> Infection Viral</td><td>30</td><td>(19.4)</td><td>41</td><td>(25.8)</td></tr><tr><td><content styleCode="bold underline">Digestive System</content></td><td/><td/><td/><td/></tr><tr><td> Abdominal Pain</td><td>67</td><td>(43.2)</td><td>70</td><td>(44.0)</td></tr><tr><td> Cholecystitis</td><td>8</td><td>(5.2)</td><td>7</td><td>(4.4)</td></tr><tr><td> Constipation</td><td>15</td><td>(9.7)</td><td>14</td><td>(8.8)</td></tr><tr><td> Diarrhea</td><td>42</td><td>(27.1)</td><td>34</td><td>(21.4)</td></tr><tr><td> Dyspepsia</td><td>26</td><td>(16.8)</td><td>18</td><td>(11.3)</td></tr><tr><td> Flatulence</td><td>12</td><td>(7.7)</td><td>12</td><td>(7.5)</td></tr><tr><td> Gastrointestinal Disorder</td><td>6</td><td>(3.9)</td><td>8</td><td>(5.0)</td></tr><tr><td> Nausea</td><td>22</td><td>(14.2)</td><td>27</td><td>(17.0)</td></tr><tr><td> Vomiting</td><td>15</td><td>(9.7)</td><td>11</td><td>(6.9)</td></tr><tr><td><content styleCode="bold underline">Musculoskeletal System</content></td><td/><td/><td/><td/></tr><tr><td> Arthralgia</td><td>12</td><td>(7.7)</td><td>24</td><td>(15.1)</td></tr><tr><td> Arthritis</td><td>9</td><td>(5.8)</td><td>4</td><td>(2.5)</td></tr><tr><td> Back Pain</td><td>11</td><td>(7.1)</td><td>18</td><td>(11.3)</td></tr><tr><td> Myalgia</td><td>9</td><td>(5.8)</td><td>9</td><td>(5.7)</td></tr><tr><td><content styleCode="bold underline">Nervous System</content></td><td/><td/><td/><td/></tr><tr><td> Headache</td><td>28</td><td>(18.1)</td><td>34</td><td>(21.4)</td></tr><tr><td> Insomnia</td><td>3</td><td>(1.9)</td><td>8</td><td>(5.0)</td></tr><tr><td><content styleCode="bold underline">Respiratory System</content></td><td/><td/><td/><td/></tr><tr><td> Bronchitis</td><td>10</td><td>(6.5)</td><td>6</td><td>(3.8)</td></tr><tr><td> Coughing</td><td>11</td><td>(7.1)</td><td>7</td><td>(4.4)</td></tr><tr><td> Pharyngitis</td><td>13</td><td>(8.4)</td><td>5</td><td>(3.1)</td></tr><tr><td> Rhinitis</td><td>8</td><td>(5.2)</td><td>11</td><td>(6.9)</td></tr><tr><td> Sinusitis</td><td>17</td><td>(11.0)</td><td>18</td><td>(11.3)</td></tr><tr><td> Upper Respiratory Tract Infection</td><td>24</td><td>(15.5)</td><td>21</td><td>(13.2)</td></tr><tr><td><content styleCode="bold underline">Urogenital System</content></td><td/><td/><td/><td/></tr><tr><td>Urinary Tract Infection</td><td>10</td><td>(6.5)</td><td>7</td><td>(4.4)</td></tr></tbody></table>

<table width="90%"><caption>GALLSTONE PREVENTION</caption><col width="50%" align="left" valign="bottom"/><col width="12%" align="center" valign="bottom"/><col width="13%" align="center" valign="bottom"/><col width="12%" align="center" valign="bottom"/><col width="13%" align="center" valign="bottom"/><thead><tr><th/><th colspan="2"><content styleCode="underline">Ursodiol</content></th><th colspan="2"><content styleCode="underline">Placebo</content></th></tr><tr><th/><th colspan="2">600 mg (N=322)</th><th colspan="2">(N=325)</th></tr><tr><th/><th>N</th><th>(%)</th><th>N</th><th>(%)</th></tr></thead><tbody><tr><td><content styleCode="bold underline">Body as a Whole</content></td><td/><td/><td/><td/></tr><tr><td> Fatigue</td><td>25</td><td>(7.8)</td><td>33</td><td>(10.2)</td></tr><tr><td> Infection Viral</td><td>29</td><td>(9.0)</td><td>29</td><td>(8.9)</td></tr><tr><td> Influenza-like Symptoms</td><td>21</td><td>(6.5)</td><td>19</td><td>(5.8)</td></tr><tr><td><content styleCode="bold underline">Digestive System</content></td><td/><td/><td/><td/></tr><tr><td> Abdominal Pain</td><td>20</td><td>(6.2)</td><td>39</td><td>(12.0)</td></tr><tr><td> Constipation</td><td>85</td><td>(26.4)</td><td>72</td><td>(22.2)</td></tr><tr><td> Diarrhea</td><td>81</td><td>(25.2)</td><td>68</td><td>(20.9)</td></tr><tr><td> Flatulence</td><td>15</td><td>(4.7)</td><td>24</td><td>(7.4)</td></tr><tr><td> Nausea</td><td>56</td><td>(17.4)</td><td>43</td><td>(13.2)</td></tr><tr><td> Vomiting</td><td>44</td><td>(13.7)</td><td>44</td><td>(13.5)</td></tr><tr><td><content styleCode="bold underline">Musculoskeletal System</content></td><td/><td/><td/><td/></tr><tr><td> Back Pain</td><td>38</td><td>(11.8)</td><td>21</td><td>(6.5)</td></tr><tr><td> Musculoskeletal Pain</td><td>19</td><td>(5.9)</td><td>15</td><td>(4.6)</td></tr><tr><td><content styleCode="bold underline">Nervous System</content></td><td/><td/><td/><td/></tr><tr><td> Dizziness</td><td>53</td><td>(16.5)</td><td>42</td><td>(12.9)</td></tr><tr><td> Headache</td><td>80</td><td>(24.8)</td><td>78</td><td>(24.0)</td></tr><tr><td><content styleCode="bold underline">Respiratory System</content></td><td/><td/><td/><td/></tr><tr><td> Pharyngitis</td><td>10</td><td>(3.1)</td><td>19</td><td>(5.8)</td></tr><tr><td> Sinusitis</td><td>17</td><td>(5.3)</td><td>18</td><td>(5.5)</td></tr><tr><td> Upper Respiratory Tract Infection</td><td>40</td><td>(12.4)</td><td>35</td><td>(10.8)</td></tr><tr><td><content styleCode="bold underline">Skin and Appendages</content></td><td/><td/><td/><td/></tr><tr><td> Alopecia</td><td>17</td><td>(5.3)</td><td>8</td><td>(2.5)</td></tr><tr><td><content styleCode="bold underline">Urogenital System</content></td><td/><td/><td/><td/></tr><tr><td> Dysmenorrhea</td><td>18</td><td>(5.6)</td><td>19</td><td>(5.8)</td></tr></tbody></table>