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
- VGYAAN Pharmaceuticals LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- db43354d-4d77-4241-af4e-5cfa6f6cd296
- SPL ID
- 062ebe65-b4e7-2fb9-e063-6294a90a5caa
- Version
- 5
- Effective date
- 2023-09-25
- Source export date
- 2026-08-01
- 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/2026-08-01/d245bd7ce31d1d8ed63276109973402ece6c44860774da30f25b731cd7418983/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
- Import run
- 20260801T225920Z
- Imported at
- 2026-08-01 23:32:31
Harmonized routes table| Harmonized routes |
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| 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 · 12 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 Capsules 8 - 10 mg/kg/day (N = 155) Placebo (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 Capsules 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)
adverse reactions table
<table width="80%" cellspacing="5" cellpadding="5"><col width="40%"/><col width="15%"/><col width="15%"/><col width="15%"/><col width="15%"/><tbody><tr><td rowspan="2" styleCode="Botrule Lrule Rrule Toprule" valign="top"/><td colspan="2" align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Ursodiol Capsules</content></paragraph><paragraph>8 - 10 mg/kg/day</paragraph><paragraph>(N = 155)</paragraph></td><td colspan="2" align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Placebo</content></paragraph><paragraph/><paragraph>(N = 159)</paragraph></td></tr><tr><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>N</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(%)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>N</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(%)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Body as a Whole</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Allergy</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(5.2)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>7</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(4.4)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Chest Pain</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>5</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(3.2)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>10</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(6.3)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Fatigue</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>7</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(4.5)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(5.0)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Infection Viral</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>30</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(19.4)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>41</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(25.8)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Digestive System</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Abdominal Pain</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>67</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(43.2)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>70</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(44.0)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Cholecystitis</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(5.2)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>7</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(4.4)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Constipation</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>15</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(9.7)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>14</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(8.8)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Diarrhea</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>42</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(27.1)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>34</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(21.4)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Dyspepsia</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>26</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(16.8)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(11.3)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Flatulence</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>12</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(7.7)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>12</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(7.5)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Gastrointestinal Disorder</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>6</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(3.9)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(5.0)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Nausea</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>22</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(14.2)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>27</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(17.0)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Vomiting</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>15</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(9.7)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>11</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(6.9)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Musculoskeletal System</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Arthralgia</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>12</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(7.7)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>24</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(15.1)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Arthritis</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>9</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(5.8)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>4</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(2.5)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Back Pain</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>11</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(7.1)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(11.3)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Myalgia</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>9</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(5.8)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>9</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(5.7)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Nervous System</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Headache</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>28</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(18.1)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>34</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(21.4)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Insomnia</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>3</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(1.9)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(5.0)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Respiratory System</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Bronchitis</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>10</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(6.5)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>6</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(3.8)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Coughing</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>11</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(7.1)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>7</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(4.4)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Pharyngitis</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>13</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(8.4)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>5</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(3.1)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Rhinitis</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(5.2)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>11</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(6.9)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Sinusitis</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>17</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(11.0)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(11.3)</paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Upper Respiratory Tract Infection</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>24</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(15.5)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>21</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(13.2)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph styleCode="First TableParagraph"><content styleCode="bold">Urogenital System</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph styleCode="First TableParagraph">Urinary Tract Infection</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph styleCode="First TableParagraph">10</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph styleCode="First TableParagraph">(6.5)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph styleCode="First TableParagraph">7</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph styleCode="First TableParagraph">(4.4)</paragraph></td></tr></tbody></table>
adverse reactions table
<table width="80%" cellspacing="5" cellpadding="5"><col width="40%"/><col width="15%"/><col width="15%"/><col width="15%"/><col width="15%"/><tbody><tr><td rowspan="2" styleCode="Botrule Lrule Rrule Toprule" valign="top"/><td colspan="2" align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Ursodiol Capsules</content></paragraph><paragraph>600 mg</paragraph><paragraph>(N = 322)</paragraph></td><td colspan="2" align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Placebo</content></paragraph><paragraph>(N = 325)</paragraph></td></tr><tr><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>N</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(%)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>N</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(%)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Body as a Whole</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Fatigue</paragraph><paragraph>Infection Viral</paragraph><paragraph>Influenza-like Symptoms</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>25</paragraph><paragraph>29</paragraph><paragraph>21</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(7.8)</paragraph><paragraph>(9.0)</paragraph><paragraph>(6.5)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>33</paragraph><paragraph>29</paragraph><paragraph>19</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(10.2)</paragraph><paragraph>(8.9)</paragraph><paragraph>(5.8)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Digestive System</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Abdominal Pain</paragraph><paragraph>Constipation</paragraph><paragraph>Diarrhea</paragraph><paragraph>Flatulence</paragraph><paragraph>Nausea</paragraph><paragraph>Vomiting</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>20</paragraph><paragraph>85</paragraph><paragraph>81</paragraph><paragraph>15</paragraph><paragraph>56</paragraph><paragraph>44</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" 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 align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>39</paragraph><paragraph>72</paragraph><paragraph>68</paragraph><paragraph>24</paragraph><paragraph>43</paragraph><paragraph>44</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" 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="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Musculoskeletal System</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Back Pain</paragraph><paragraph>Musculoskeletal Pain</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>38</paragraph><paragraph>19</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(11.8)</paragraph><paragraph>(5.9)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>21</paragraph><paragraph>15</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(6.5)</paragraph><paragraph>(4.6)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Nervous System</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Dizziness</paragraph><paragraph>Headache</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>53</paragraph><paragraph>80</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(16.5)</paragraph><paragraph>(24.8)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>42</paragraph><paragraph>78</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(12.9)</paragraph><paragraph>(24.0)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Respiratory System</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Pharyngitis</paragraph><paragraph>Sinusitis</paragraph><paragraph>Upper Respiratory Tract Infection</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>10</paragraph><paragraph>17</paragraph><paragraph>40</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(3.1)</paragraph><paragraph>(5.3)</paragraph><paragraph>(12.4)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>19</paragraph><paragraph>18</paragraph><paragraph>35</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(5.8)</paragraph><paragraph>(5.5)</paragraph><paragraph>(10.8)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Skin and Appendages</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Alopecia</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>17</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(5.3)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(2.5)</paragraph></td></tr><tr><td colspan="5" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Urogenital System</content></paragraph></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>Dysmenorrhea</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>18</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(5.6)</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>19</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph>(5.8)</paragraph></td></tr></tbody></table>