Home FDA labels 5912e81a-cccb-4a5c-beab-dd003aa2ccdb 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 Actavis Pharma, Inc.
Product type HUMAN PRESCRIPTION DRUG
SPL set ID a061bb07-a85d-4b08-877f-ce02156f0de7
SPL ID 5912e81a-cccb-4a5c-beab-dd003aa2ccdb
Version 15
Effective date 2023-07-31
Source export date 2026-09-28
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:18:32 Harmonized routes table Harmonized routes 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.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
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 Actigall until a clinical evaluation has been conducted.
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 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="440.1pt" cellspacing="0" cellpadding="0" border="1"><col/><col/><col/><col/><col/><thead><tr><th align="center" styleCode=" Botrule Toprule Lrule Rrule" colspan="5">GALLSTONE DISSOLUTION</th></tr></thead><tbody><tr><td styleCode=" Botrule Toprule Lrule Rrule"/><td colspan="2" styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Ursodiol</content></paragraph></td><td colspan="2" styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Placebo</content></paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"/><td colspan="2" styleCode=" Botrule Toprule Lrule Rrule"><paragraph>8 - 10 mg/kg/day (N = 155)</paragraph></td><td colspan="2" styleCode=" Botrule Toprule Lrule Rrule"><paragraph> (N = 159)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>N</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(%)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>N</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(%)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Body as a Whole</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>Allergy</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>8</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.2)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>7</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(4.4)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Chest Pain</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>5</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(3.2)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>10</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(6.3)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Fatigue</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>7</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(4.5)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>8</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.0)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Infection Viral</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>30</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(19.4)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>41</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(25.8)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Digestive System</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Abdominal Pain</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>67</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(43.2)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>70</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(44.0)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Cholecystitis</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>8</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.2)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>7</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(4.4)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Constipation</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>15</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(9.7)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>14</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(8.8)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Diarrhea</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>42</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(27.1)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>34</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(21.4)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Dyspepsia</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>26</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(16.8)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>18</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(11.3)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Flatulence</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>12</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(7.7)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>12</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(7.5)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Gastrointestinal Disorder</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>6</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(3.9)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>8</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.0)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Nausea</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>22</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(14.2)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>27</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(17.0)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Vomiting</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>15</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(9.7)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>11</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(6.9)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Musculoskeletal System</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Arthralgia</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>12</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(7.7)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>24</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(15.1)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Arthritis</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>9</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.8)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>4</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(2.5)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Back Pain</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>11</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(7.1)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>18</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(11.3)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Myalgia</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>9</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.8)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>9</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.7)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Nervous System</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Headache</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>28</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(18.1)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>34</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(21.4)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Insomnia</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>3</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(1.9)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>8</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.0)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Respiratory System</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Bronchitis</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>10</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(6.5)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>6</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(3.8)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Coughing</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>11</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(7.1)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>7</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(4.4)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Pharyngitis</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>13</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(8.4)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>5</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(3.1)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Rhinitis</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>8</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.2)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>11</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(6.9)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Sinusitis</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>17</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(11.0)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>18</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(11.3)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Upper Respiratory Tract Infection</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>24</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(15.5)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>21</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(13.2)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Urogenital System</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Urinary Tract Infection</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>10</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(6.5)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>7</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(4.4)</paragraph></td></tr></tbody></table>
adverse reactions table <table width="442.55pt" cellspacing="0" cellpadding="0" border="1"><col/><col/><col/><col/><col/><thead><tr><th align="center" styleCode=" Botrule Toprule Lrule Rrule" colspan="5">GALLSTONE PREVENTION</th></tr></thead><tbody><tr><td styleCode=" Botrule Toprule Lrule Rrule"/><td colspan="2" styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Ursodiol</content></paragraph></td><td colspan="2" styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Placebo</content></paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"/><td colspan="2" styleCode=" Botrule Toprule Lrule Rrule"><paragraph>600 mg (N = 322)</paragraph></td><td colspan="2" styleCode=" Botrule Toprule Lrule Rrule"><paragraph> (N = 325)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>N</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(%)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>N</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(%)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Body as a Whole</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Fatigue</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>25</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(7.8)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>33</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(10.2)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Infection Viral</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>29</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(9.0)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>29</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(8.9)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Influenza-like Symptoms</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>21</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(6.5)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>19</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.8)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Digestive System</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Abdominal Pain</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>20</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(6.2)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>39</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(12.0)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Constipation</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>85</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(26.4)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>72</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(22.2)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Diarrhea</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>81</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(25.2)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>68</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(20.9)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Flatulence</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>15</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(4.7)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>24</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(7.4)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Nausea</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>56</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(17.4)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>43</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(13.2)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Vomiting</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>44</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(13.7)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>44</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(13.5)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Musculoskeletal System</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Back Pain</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>38</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(11.8)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>21</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(6.5)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Musculoskeletal Pain</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>19</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.9)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>15</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(4.6)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Nervous System</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Dizziness</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>53</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(16.5)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>42</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(12.9)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Headache</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>80</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(24.8)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>78</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(24.0)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Respiratory System</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Pharyngitis</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>10</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(3.1)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>19</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.8)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Sinusitis</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>17</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.3)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>18</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.5)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Upper Respiratory Tract Infection</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>40</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(12.4)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>35</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(10.8)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Skin and Appendages</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Alopecia</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>17</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.3)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>8</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(2.5)</paragraph></td></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph><content styleCode="bold">Urogenital System</content></paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/><td styleCode=" Botrule Toprule Lrule Rrule"/></tr><tr><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph> Dysmenorrhea</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>18</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.6)</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>19</paragraph></td><td styleCode=" Botrule Toprule Lrule Rrule"><paragraph>(5.8)</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.