Home FDA labels 37f083e8-2223-360b-e063-6294a90aa549 Ursodiol 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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Brand name Ursodiol
Generic name URSODIOL
Manufacturer American Health Packaging
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 9ae9412b-36d5-4634-8d5c-cc96110821c0
SPL ID 37f083e8-2223-360b-e063-6294a90aa549
Version 10
Effective date 2025-06-19
Source export date 2026-09-28
Source partition 12
Source file https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
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warnings WARNINGS Enteroliths in Patients with Risk for Intestinal Stenosis or Stasis There have been rare postmarketing reports of ursodiol-treated patients who developed enteroliths (bezoars) resulting in obstructive symptoms that required surgical intervention. These patients had medical conditions that predisposed them to intestinal stenosis or stasis (e.g., surgical enteroanastomoses, Crohn's disease). If a patient presents with obstructive gastrointestinal symptoms, hold Ursodiol until a clinical evaluation has been conducted.
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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) Postmarketing 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)
adverse reactions table <table width="100%"><colgroup><col width="38%"/><col width="15%"/><col width="16%"/><col width="14%"/><col width="16%"/></colgroup><thead><tr><th align="center" colspan="5" styleCode="Toprule " valign="bottom"><content styleCode="bold"><content styleCode="underline">GALLSTONE DISSOLUTION</content></content></th></tr><tr><th align="left" valign="bottom"/><th align="center" colspan="2" valign="bottom"><content styleCode="bold"><content styleCode="underline">Ursodiol</content></content></th><th align="center" colspan="2" valign="bottom"><content styleCode="bold"><content styleCode="underline">Placebo</content></content></th></tr><tr><th align="left" valign="bottom"/><th align="center" colspan="2" valign="bottom"><content styleCode="bold">8-10 mg/kg/day</content> <content styleCode="bold">(N=155)</content></th><th align="center" colspan="2" valign="bottom"><content styleCode="bold">(N=159)</content></th></tr><tr><th align="left" styleCode="Botrule " valign="bottom"/><th align="center" styleCode="Botrule " valign="bottom"><content styleCode="bold">N</content></th><th align="center" styleCode="Botrule " valign="bottom"><content styleCode="bold">(%)</content></th><th align="center" styleCode="Botrule " valign="bottom"><content styleCode="bold">N</content></th><th align="center" styleCode="Botrule " valign="bottom"><content styleCode="bold">(%)</content></th></tr></thead><tbody><tr><td styleCode="Toprule " valign="bottom"><paragraph><content styleCode="bold"><content styleCode="underline">Body as a Whole</content></content></paragraph></td><td styleCode="Toprule " valign="bottom"/><td styleCode="Toprule " valign="bottom"/><td styleCode="Toprule " valign="bottom"/><td styleCode="Toprule " valign="bottom"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Allergy </paragraph></td><td align="center" valign="bottom"><paragraph>8</paragraph></td><td align="center" valign="bottom"><paragraph>(5.2)</paragraph></td><td align="center" valign="bottom"><paragraph>7</paragraph></td><td align="center" valign="bottom"><paragraph>(4.4)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Chest Pain </paragraph></td><td align="center" valign="bottom"><paragraph>5</paragraph></td><td align="center" valign="bottom"><paragraph>(3.2)</paragraph></td><td align="center" valign="bottom"><paragraph>10</paragraph></td><td align="center" valign="bottom"><paragraph>(6.3)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Fatigue </paragraph></td><td align="center" valign="bottom"><paragraph>7</paragraph></td><td align="center" valign="bottom"><paragraph>(4.5)</paragraph></td><td align="center" valign="bottom"><paragraph>8</paragraph></td><td align="center" valign="bottom"><paragraph>(5.0)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Infection Viral </paragraph></td><td align="center" valign="bottom"><paragraph>30</paragraph></td><td align="center" valign="bottom"><paragraph>(19.4)</paragraph></td><td align="center" valign="bottom"><paragraph>41</paragraph></td><td align="center" valign="bottom"><paragraph>(25.8)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"><content styleCode="underline">Digestive System</content></content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Abdominal Pain </paragraph></td><td align="center" valign="bottom"><paragraph>67</paragraph></td><td align="center" valign="bottom"><paragraph>(43.2)</paragraph></td><td align="center" valign="bottom"><paragraph>70</paragraph></td><td align="center" valign="bottom"><paragraph>(44.0)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Cholecystitis </paragraph></td><td align="center" valign="bottom"><paragraph>8</paragraph></td><td align="center" valign="bottom"><paragraph>(5.2)</paragraph></td><td align="center" valign="bottom"><paragraph>7</paragraph></td><td align="center" valign="bottom"><paragraph>(4.4)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Constipation </paragraph></td><td align="center" valign="bottom"><paragraph>15</paragraph></td><td align="center" valign="bottom"><paragraph>(9.7)</paragraph></td><td align="center" valign="bottom"><paragraph>14</paragraph></td><td align="center" valign="bottom"><paragraph>(8.8)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Diarrhea </paragraph></td><td align="center" valign="bottom"><paragraph>42</paragraph></td><td align="center" valign="bottom"><paragraph>(27.1)</paragraph></td><td align="center" valign="bottom"><paragraph>34</paragraph></td><td align="center" valign="bottom"><paragraph>(21.4)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Dyspepsia </paragraph></td><td align="center" valign="bottom"><paragraph>26</paragraph></td><td align="center" valign="bottom"><paragraph>(16.8)</paragraph></td><td align="center" valign="bottom"><paragraph>18</paragraph></td><td align="center" valign="bottom"><paragraph>(11.3)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Flatulence </paragraph></td><td align="center" valign="bottom"><paragraph>12</paragraph></td><td align="center" valign="bottom"><paragraph>(7.7)</paragraph></td><td align="center" valign="bottom"><paragraph>12</paragraph></td><td align="center" valign="bottom"><paragraph>(7.5)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Gastrointestinal Disorder </paragraph></td><td align="center" valign="bottom"><paragraph>6</paragraph></td><td align="center" valign="bottom"><paragraph>(3.9)</paragraph></td><td align="center" valign="bottom"><paragraph>8</paragraph></td><td align="center" valign="bottom"><paragraph>(5.0)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Nausea </paragraph></td><td align="center" valign="bottom"><paragraph>22</paragraph></td><td align="center" valign="bottom"><paragraph>(14.2)</paragraph></td><td align="center" valign="bottom"><paragraph>27</paragraph></td><td align="center" valign="bottom"><paragraph>(17.0)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Vomiting </paragraph></td><td align="center" valign="bottom"><paragraph>15</paragraph></td><td align="center" valign="bottom"><paragraph>(9.7)</paragraph></td><td align="center" valign="bottom"><paragraph>11</paragraph></td><td align="center" valign="bottom"><paragraph>(6.9)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"><content styleCode="underline">Musculoskeletal System</content></content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Arthralgia </paragraph></td><td align="center" valign="bottom"><paragraph>12</paragraph></td><td align="center" valign="bottom"><paragraph>(7.7)</paragraph></td><td align="center" valign="bottom"><paragraph>24</paragraph></td><td align="center" valign="bottom"><paragraph>(15.1)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Arthritis </paragraph></td><td align="center" valign="bottom"><paragraph>9</paragraph></td><td align="center" valign="bottom"><paragraph>(5.8)</paragraph></td><td align="center" valign="bottom"><paragraph>4</paragraph></td><td align="center" valign="bottom"><paragraph>(2.5)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Back Pain </paragraph></td><td align="center" valign="bottom"><paragraph>11</paragraph></td><td align="center" valign="bottom"><paragraph>(7.1)</paragraph></td><td align="center" valign="bottom"><paragraph>18</paragraph></td><td align="center" valign="bottom"><paragraph>(11.3)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Myalgia </paragraph></td><td align="center" valign="bottom"><paragraph>9</paragraph></td><td align="center" valign="bottom"><paragraph>(5.8)</paragraph></td><td align="center" valign="bottom"><paragraph>9</paragraph></td><td align="center" valign="bottom"><paragraph>(5.7)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"><content styleCode="underline">Nervous System</content></content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Headache </paragraph></td><td align="center" valign="bottom"><paragraph>28</paragraph></td><td align="center" valign="bottom"><paragraph>(18.1)</paragraph></td><td align="center" valign="bottom"><paragraph>34</paragraph></td><td align="center" valign="bottom"><paragraph>(21.4)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Insomnia </paragraph></td><td align="center" valign="bottom"><paragraph>3</paragraph></td><td align="center" valign="bottom"><paragraph>(1.9)</paragraph></td><td align="center" valign="bottom"><paragraph>8</paragraph></td><td align="center" valign="bottom"><paragraph>(5.0)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"><content styleCode="underline">Respiratory System</content></content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Bronchitis </paragraph></td><td align="center" valign="bottom"><paragraph>10</paragraph></td><td align="center" valign="bottom"><paragraph>(6.5)</paragraph></td><td align="center" valign="bottom"><paragraph>6</paragraph></td><td align="center" valign="bottom"><paragraph>(3.8)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Coughing </paragraph></td><td align="center" valign="bottom"><paragraph>11</paragraph></td><td align="center" valign="bottom"><paragraph>(7.1)</paragraph></td><td align="center" valign="bottom"><paragraph>7</paragraph></td><td align="center" valign="bottom"><paragraph>(4.4)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Pharyngitis </paragraph></td><td align="center" valign="bottom"><paragraph>13</paragraph></td><td align="center" valign="bottom"><paragraph>(8.4)</paragraph></td><td align="center" valign="bottom"><paragraph>5</paragraph></td><td align="center" valign="bottom"><paragraph>(3.1)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Rhinitis </paragraph></td><td align="center" valign="bottom"><paragraph>8</paragraph></td><td align="center" valign="bottom"><paragraph>(5.2)</paragraph></td><td align="center" valign="bottom"><paragraph>11</paragraph></td><td align="center" valign="bottom"><paragraph>(6.9)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Sinusitis </paragraph></td><td align="center" valign="bottom"><paragraph>17</paragraph></td><td align="center" valign="bottom"><paragraph>(11.0)</paragraph></td><td align="center" valign="bottom"><paragraph>18</paragraph></td><td align="center" valign="bottom"><paragraph>(11.3)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Upper Respiratory Tract Infection </paragraph></td><td align="center" valign="bottom"><paragraph>24</paragraph></td><td align="center" valign="bottom"><paragraph>(15.5)</paragraph></td><td align="center" valign="bottom"><paragraph>21</paragraph></td><td align="center" valign="bottom"><paragraph>(13.2)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"><content styleCode="underline">Urogenital System</content></content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td styleCode="Botrule " valign="bottom"><paragraph><content styleCode="bold"> </content>Urinary Tract Infection </paragraph></td><td align="center" styleCode="Botrule " valign="bottom"><paragraph>10</paragraph></td><td align="center" styleCode="Botrule " valign="bottom"><paragraph>(6.5)</paragraph></td><td align="center" styleCode="Botrule " valign="bottom"><paragraph>7</paragraph></td><td align="center" styleCode="Botrule " valign="bottom"><paragraph>(4.4)</paragraph></td></tr></tbody></table>
adverse reactions table <table width="100%"><colgroup><col width="37%"/><col width="15%"/><col width="16%"/><col width="15%"/><col width="16%"/></colgroup><thead><tr><th align="center" colspan="5" styleCode="Toprule " valign="bottom"><content styleCode="bold"><content styleCode="underline">GALLSTONE PREVENTION</content></content></th></tr><tr><th align="left" valign="bottom"/><th align="center" colspan="2" valign="bottom"><content styleCode="bold"><content styleCode="underline">Ursodiol</content></content></th><th align="center" colspan="2" valign="bottom"><content styleCode="bold"><content styleCode="underline">Placebo</content></content></th></tr><tr><th align="left" valign="bottom"/><th align="center" colspan="2" valign="bottom"><content styleCode="bold">600 mg</content> <content styleCode="bold">(N=322)</content></th><th align="center" colspan="2" valign="bottom"><content styleCode="bold">(N=325)</content></th></tr><tr><th align="left" styleCode="Botrule " valign="bottom"/><th align="center" styleCode="Botrule " valign="bottom"><content styleCode="bold">N</content></th><th align="center" styleCode="Botrule " valign="bottom"><content styleCode="bold">(%)</content></th><th align="center" styleCode="Botrule " valign="bottom"><content styleCode="bold">N</content></th><th align="center" styleCode="Botrule " valign="bottom"><content styleCode="bold">(%)</content></th></tr></thead><tbody><tr><td styleCode="Toprule " valign="bottom"><paragraph><content styleCode="bold"><content styleCode="underline">Body as a Whole</content></content></paragraph></td><td styleCode="Toprule " valign="bottom"/><td styleCode="Toprule " valign="bottom"/><td styleCode="Toprule " valign="bottom"/><td styleCode="Toprule " valign="bottom"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Fatigue </paragraph></td><td align="center" valign="bottom"><paragraph>25</paragraph></td><td align="center" valign="bottom"><paragraph>(7.8)</paragraph></td><td align="center" valign="bottom"><paragraph>33</paragraph></td><td align="center" valign="bottom"><paragraph>(10.2)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Infection Viral </paragraph></td><td align="center" valign="bottom"><paragraph>29</paragraph></td><td align="center" valign="bottom"><paragraph>(9.0)</paragraph></td><td align="center" valign="bottom"><paragraph>29</paragraph></td><td align="center" valign="bottom"><paragraph>(8.9)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Influenza-like Symptoms </paragraph></td><td align="center" valign="bottom"><paragraph>21</paragraph></td><td align="center" valign="bottom"><paragraph>(6.5)</paragraph></td><td align="center" valign="bottom"><paragraph>19</paragraph></td><td align="center" valign="bottom"><paragraph>(5.8)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"><content styleCode="underline">Digestive System</content></content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Abdominal Pain </paragraph></td><td align="center" valign="bottom"><paragraph>20</paragraph></td><td align="center" valign="bottom"><paragraph>(6.2)</paragraph></td><td align="center" valign="bottom"><paragraph>39</paragraph></td><td align="center" valign="bottom"><paragraph>(12.0)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Constipation </paragraph></td><td align="center" valign="bottom"><paragraph>85</paragraph></td><td align="center" valign="bottom"><paragraph>(26.4)</paragraph></td><td align="center" valign="bottom"><paragraph>72</paragraph></td><td align="center" valign="bottom"><paragraph>(22.2)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Diarrhea </paragraph></td><td align="center" valign="bottom"><paragraph>81</paragraph></td><td align="center" valign="bottom"><paragraph>(25.2)</paragraph></td><td align="center" valign="bottom"><paragraph>68</paragraph></td><td align="center" valign="bottom"><paragraph>(20.9)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Flatulence </paragraph></td><td align="center" valign="bottom"><paragraph>15</paragraph></td><td align="center" valign="bottom"><paragraph>(4.7)</paragraph></td><td align="center" valign="bottom"><paragraph>24</paragraph></td><td align="center" valign="bottom"><paragraph>(7.4)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Nausea </paragraph></td><td align="center" valign="bottom"><paragraph>56</paragraph></td><td align="center" valign="bottom"><paragraph>(17.4)</paragraph></td><td align="center" valign="bottom"><paragraph>43</paragraph></td><td align="center" valign="bottom"><paragraph>(13.2)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Vomiting </paragraph></td><td align="center" valign="bottom"><paragraph>44</paragraph></td><td align="center" valign="bottom"><paragraph>(13.7)</paragraph></td><td align="center" valign="bottom"><paragraph>44</paragraph></td><td align="center" valign="bottom"><paragraph>(13.5)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"><content styleCode="underline">Musculoskeletal System</content></content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Back Pain </paragraph></td><td align="center" valign="bottom"><paragraph>38</paragraph></td><td align="center" valign="bottom"><paragraph>(11.8)</paragraph></td><td align="center" valign="bottom"><paragraph>21</paragraph></td><td align="center" valign="bottom"><paragraph>(6.5)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Musculoskeletal Pain </paragraph></td><td align="center" valign="bottom"><paragraph>19</paragraph></td><td align="center" valign="bottom"><paragraph>(5.9)</paragraph></td><td align="center" valign="bottom"><paragraph>15</paragraph></td><td align="center" valign="bottom"><paragraph>(4.6)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"><content styleCode="underline">Nervous System</content></content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Dizziness </paragraph></td><td align="center" valign="bottom"><paragraph>53</paragraph></td><td align="center" valign="bottom"><paragraph>(16.5)</paragraph></td><td align="center" valign="bottom"><paragraph>42</paragraph></td><td align="center" valign="bottom"><paragraph>(12.9)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Headache </paragraph></td><td align="center" valign="bottom"><paragraph>80</paragraph></td><td align="center" valign="bottom"><paragraph>(24.8)</paragraph></td><td align="center" valign="bottom"><paragraph>78</paragraph></td><td align="center" valign="bottom"><paragraph>(24.0)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"><content styleCode="underline">Respiratory System</content></content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Pharyngitis </paragraph></td><td align="center" valign="bottom"><paragraph>10</paragraph></td><td align="center" valign="bottom"><paragraph>(3.1)</paragraph></td><td align="center" valign="bottom"><paragraph>19</paragraph></td><td align="center" valign="bottom"><paragraph>(5.8)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Sinusitis </paragraph></td><td align="center" valign="bottom"><paragraph>17</paragraph></td><td align="center" valign="bottom"><paragraph>(5.3)</paragraph></td><td align="center" valign="bottom"><paragraph>18</paragraph></td><td align="center" valign="bottom"><paragraph>(5.5)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Upper Respiratory Tract Infection </paragraph></td><td align="center" valign="bottom"><paragraph>40</paragraph></td><td align="center" valign="bottom"><paragraph>(12.4)</paragraph></td><td align="center" valign="bottom"><paragraph>35</paragraph></td><td align="center" valign="bottom"><paragraph>(10.8)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"><content styleCode="underline">Skin and Appendages</content></content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"> </content>Alopecia </paragraph></td><td align="center" valign="bottom"><paragraph>17</paragraph></td><td align="center" valign="bottom"><paragraph>(5.3)</paragraph></td><td align="center" valign="bottom"><paragraph>8</paragraph></td><td align="center" valign="bottom"><paragraph>(2.5)</paragraph></td></tr><tr><td valign="bottom"><paragraph><content styleCode="bold"><content styleCode="underline">Urogenital System</content></content></paragraph></td><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/><td valign="bottom"/></tr><tr><td styleCode="Botrule " valign="bottom"><paragraph><content styleCode="bold"> </content>Dysmenorrhea </paragraph></td><td align="center" styleCode="Botrule " valign="bottom"><paragraph>18</paragraph></td><td align="center" styleCode="Botrule " valign="bottom"><paragraph>(5.6)</paragraph></td><td align="center" styleCode="Botrule " valign="bottom"><paragraph>19</paragraph></td><td align="center" styleCode="Botrule " valign="bottom"><paragraph>(5.8)</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.