Home FDA labels 5cab9ae3-fb31-4848-9115-460a8b693042 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 Zydus Lifesciences Limited
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 6163fc42-5910-4e19-9e32-3d8e81f50128
SPL ID 5cab9ae3-fb31-4848-9115-460a8b693042
Version 3
Effective date 2024-02-15
Source export date 2026-10-12
Source partition 1
Source file https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:26:54 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 mg/kg/day to 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) 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 600 mg (N = 322) Placebo (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) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 ID="ID41" width="548" styleCode="Noautorules"><caption/><col width="180"/><col width="94"/><col width="85"/><col width="94"/><col width="95"/><tbody><tr><td colspan="5" valign="top" styleCode="Lrule Toprule Botrule Rrule" align="left"><content styleCode="bold"><content styleCode="underline">GALLSTONE DISSOLUTION</content></content> </td></tr><tr><td rowspan="3" valign="top" styleCode="Lrule Botrule Rrule"/><td colspan="2" valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"><content styleCode="underline">Ursodiol</content></content> </td><td colspan="2" valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"><content styleCode="underline">Placebo</content></content> </td></tr><tr><td colspan="2" valign="top" styleCode=" Botrule Rrule" align="center"> 8 mg/kg/day to 10 mg/kg/day (N = 155) </td><td colspan="2" valign="top" styleCode=" Botrule Rrule" align="center"> (N = 159) </td></tr><tr><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="underline">N</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="underline">(%)</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="underline">N</content> </td><td valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="underline">(%)</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"><content styleCode="underline">Body as a Whole</content></content> </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Allergy </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 8 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.2) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (4.4) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Chest Pain </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 5 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (3.2) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 10 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (6.3) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Fatigue </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (4.5) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 8 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Infection Viral </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 30 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (19.4) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 41 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (25.8) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"><content styleCode="underline">Digestive System</content></content> </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Abdominal Pain </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 67 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (43.2) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 70 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (44.0) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Cholecystitis </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 8 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.2) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (4.4) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Constipation </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 15 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (9.7) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 14 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (8.8) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Diarrhea </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 42 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (27.1) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 34 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (21.4) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Dyspepsia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 26 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (16.8) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 18 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (11.3) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Flatulence </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (7.7) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (7.5) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Gastrointestinal Disorder </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (3.9) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 8 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.0) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Nausea </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 22 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (14.2) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 27 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (17.0) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Vomiting </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 15 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (9.7) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 11 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (6.9) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"><content styleCode="underline">Musculoskeletal System</content></content> </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Arthralgia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 12 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (7.7) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 24 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (15.1) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Arthritis </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 9 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.8) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 4 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (2.5) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Back Pain </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 11 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (7.1) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 18 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (11.3) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Myalgia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 9 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.8) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 9 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.7) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"><content styleCode="underline">Nervous System</content></content> </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Headache </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 28 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (18.1) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 34 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (21.4) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Insomnia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 3 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (1.9) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 8 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.0) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"><content styleCode="underline">Respiratory System</content></content> </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Bronchitis </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 10 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (6.5) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 6 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (3.8) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Coughing </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 11 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (7.1) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (4.4) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Pharyngitis </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 13 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (8.4) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 5 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (3.1) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Rhinitis </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 8 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.2) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 11 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (6.9) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Sinusitis </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 17 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (11.0) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 18 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (11.3) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Upper Respiratory Tract Infection </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 24 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (15.5) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 21 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (13.2) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"><content styleCode="underline">Urogenital System</content></content> </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Urinary Tract Infection </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 10 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (6.5) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 7 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (4.4) </td></tr></tbody></table>
adverse reactions table <table ID="ID42" width="0" styleCode="Noautorules"><caption/><col width="201"/><col width="85"/><col width="94"/><col width="94"/><col width="94"/><tbody><tr><td colspan="5" valign="top" styleCode="Lrule Toprule Botrule Rrule" align="center"><content styleCode="bold"> GALLSTONE PREVENTION</content> </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule"/><td colspan="2" valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Ursodiol</content> 600 mg (N = 322) </td><td colspan="2" valign="top" styleCode=" Botrule Rrule" align="center"><content styleCode="bold"> Placebo</content> (N = 325) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule" align="center"> N </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (%) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> N </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (%) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> </content><content styleCode="bold"> Body as a Whole</content> </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Fatigue </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 25 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (7.8) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 33 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (10.2) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Infection Viral </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 29 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (9.0) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 29 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (8.9) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Influenza-like Symptoms </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 21 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (6.5) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 19 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.8) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Digestive System</content> </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Abdominal Pain </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 20 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (6.2) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 39 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (12.0) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Constipation </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 85 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (26.4) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 72 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (22.2) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Diarrhea </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 81 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (25.2) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 68 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (20.9) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Flatulence </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 15 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (4.7) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 24 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (7.4) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Nausea </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 56 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (17.4) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 43 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (13.2) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Vomiting </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 44 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (13.7) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 44 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (13.5) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Musculoskeletal System</content> </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Back Pain </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 38 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (11.8) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 21 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (6.5) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Musculoskeletal Pain </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 19 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.9) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 15 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (4.6) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Nervous System</content> </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Dizziness </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 53 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (16.5) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 42 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (12.9) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Headache </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 80 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (24.8) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 78 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (24.0) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Respiratory System</content> </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Pharyngitis </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 10 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (3.1) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 19 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.8) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Sinusitis </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 17 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.3) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 18 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.5) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Upper Respiratory </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Tract Infection </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 40 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (12.4) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 35 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (10.8) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Skin and Appendages</content> </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Alopecia </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 17 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.3) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 8 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (2.5) </td></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"><content styleCode="bold"> Urogenital System</content> </td><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/><td valign="top" styleCode=" Botrule Rrule"/></tr><tr><td valign="top" styleCode="Lrule Botrule Rrule" align="left"> Dysmenorrhea </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 18 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.6) </td><td valign="top" styleCode=" Botrule Rrule" align="center"> 19 </td><td valign="top" styleCode=" Botrule Rrule" align="center"> (5.8) </td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.