Home FDA labels b762c96f-bb2e-4268-b71c-ccda296cb299 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 NorthStar Rx LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID dd0346e2-5ff3-4208-ad88-d09182684603
SPL ID b762c96f-bb2e-4268-b71c-ccda296cb299
Version 2
Effective date 2025-07-01
Source export date 2026-09-28
Source partition 7
Source file https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:45:52 Harmonized routes table Harmonized routes ORAL
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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 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 (5.0) 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 cellspacing="0" cellpadding="0" border="0" width="100%"><colgroup><col width="34.26%"/><col width="17.14%"/><col width="16.12%"/><col width="14.94%"/><col width="17.54%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5" align="center" valign="middle"><content styleCode="bold">GALLSTONE DISSOLUTION</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> </td><td styleCode="Rrule" colspan="2" align="center" valign="middle"><content styleCode="bold">Ursodiol</content> </td><td styleCode="Rrule" colspan="2" align="center" valign="middle"><content styleCode="bold">Placebo</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="top"> </td><td styleCode="Rrule" colspan="2" align="center" valign="middle">8 to 10 mg/kg/day (N = 155) </td><td styleCode="Rrule" colspan="2" align="center" valign="middle"> (N = 159) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle"> </td><td styleCode="Rrule" align="center" valign="middle">N </td><td styleCode="Rrule" align="center" valign="middle">(%) </td><td styleCode="Rrule" align="center" valign="middle">N </td><td styleCode="Rrule" align="center" valign="middle">(%) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5" align="justify" valign="middle"><content styleCode="bold">Body as a Whole</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Allergy </td><td styleCode="Rrule" align="center" valign="middle">8 </td><td styleCode="Rrule" align="center" valign="middle">(5.2) </td><td styleCode="Rrule" align="center" valign="middle">7<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(4.4) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Chest Pain </td><td styleCode="Rrule" align="center" valign="middle">5 </td><td styleCode="Rrule" align="center" valign="middle">(3.2) </td><td styleCode="Rrule" align="center" valign="middle">10<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(6.3) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Fatigue </td><td styleCode="Rrule" align="center" valign="middle">7 </td><td styleCode="Rrule" align="center" valign="middle">(4.5) </td><td styleCode="Rrule" align="center" valign="middle">8<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(5.0) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Infection Viral </td><td styleCode="Rrule" align="center" valign="middle">30 </td><td styleCode="Rrule" align="center" valign="middle">(19.4) </td><td styleCode="Rrule" align="center" valign="middle">41<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(25.8) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5" align="justify" valign="middle"><content styleCode="bold">Digestive System</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Abdominal Pain </td><td styleCode="Rrule" align="center" valign="middle">67 </td><td styleCode="Rrule" align="center" valign="middle">(43.2) </td><td styleCode="Rrule" align="center" valign="middle">70<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(44.0) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Cholecystitis </td><td styleCode="Rrule" align="center" valign="middle">8 </td><td styleCode="Rrule" align="center" valign="middle">(5.2) </td><td styleCode="Rrule" align="center" valign="middle">7<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(4.4) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Constipation </td><td styleCode="Rrule" align="center" valign="middle">15 </td><td styleCode="Rrule" align="center" valign="middle">(9.7) </td><td styleCode="Rrule" align="center" valign="middle">14<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(8.8) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Diarrhea </td><td styleCode="Rrule" align="center" valign="middle">42 </td><td styleCode="Rrule" align="center" valign="middle">(27.1) </td><td styleCode="Rrule" align="center" valign="middle">34<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(21.4) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Dyspepsia </td><td styleCode="Rrule" align="center" valign="middle">26 </td><td styleCode="Rrule" align="center" valign="middle">(16.8) </td><td styleCode="Rrule" align="center" valign="middle">18<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(11.3) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Flatulence </td><td styleCode="Rrule" align="center" valign="middle">12 </td><td styleCode="Rrule" align="center" valign="middle">(7.7) </td><td styleCode="Rrule" align="center" valign="middle">12<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(7.5) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Gastrointestinal Disorder </td><td styleCode="Rrule" align="center" valign="middle">6 </td><td styleCode="Rrule" align="center" valign="middle">(3.9) </td><td styleCode="Rrule" align="center" valign="middle">8<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(5.0) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Nausea </td><td styleCode="Rrule" align="center" valign="middle">22 </td><td styleCode="Rrule" align="center" valign="middle">(14.2) </td><td styleCode="Rrule" align="center" valign="middle">27<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(17.0) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Vomiting </td><td styleCode="Rrule" align="center" valign="middle">15 </td><td styleCode="Rrule" align="center" valign="middle">(9.7) </td><td styleCode="Rrule" align="center" valign="middle">11<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(6.9) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5" align="justify" valign="middle"><content styleCode="bold">Musculoskeletal System</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Arthralgia </td><td styleCode="Rrule" align="center" valign="middle">12 </td><td styleCode="Rrule" align="center" valign="middle">(7.7) </td><td styleCode="Rrule" align="center" valign="middle">24<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(15.1) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Arthritis </td><td styleCode="Rrule" align="center" valign="middle">9 </td><td styleCode="Rrule" align="center" valign="middle">(5.8) </td><td styleCode="Rrule" align="center" valign="middle">4<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(2.5) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Back Pain </td><td styleCode="Rrule" align="center" valign="middle">11 </td><td styleCode="Rrule" align="center" valign="middle">(7.1) </td><td styleCode="Rrule" align="center" valign="middle">18<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(11.3) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Myalgia </td><td styleCode="Rrule" align="center" valign="middle">9 </td><td styleCode="Rrule" align="center" valign="middle">(5.8) </td><td styleCode="Rrule" align="center" valign="middle">9<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(5.7) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5" align="justify" valign="middle"><content styleCode="bold">Nervous System</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Headache </td><td styleCode="Rrule" align="center" valign="middle">28 </td><td styleCode="Rrule" align="center" valign="middle">(18.1) </td><td styleCode="Rrule" align="center" valign="middle">34<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(21.4) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Insomnia </td><td styleCode="Rrule" align="center" valign="middle">3 </td><td styleCode="Rrule" align="center" valign="middle">(1.9) </td><td styleCode="Rrule" align="center" valign="middle">8<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(5.0) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5" align="justify" valign="middle"><content styleCode="bold">Respiratory System</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Bronchitis </td><td styleCode="Rrule" align="center" valign="middle">10 </td><td styleCode="Rrule" align="center" valign="middle">(6.5) </td><td styleCode="Rrule" align="center" valign="middle">6<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(3.8) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Coughing </td><td styleCode="Rrule" align="center" valign="middle">11 </td><td styleCode="Rrule" align="center" valign="middle">(7.1) </td><td styleCode="Rrule" align="center" valign="middle">7<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(4.4) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Pharyngitis </td><td styleCode="Rrule" align="center" valign="middle">13 </td><td styleCode="Rrule" align="center" valign="middle">(8.4) </td><td styleCode="Rrule" align="center" valign="middle">5<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(3.1) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Rhinitis </td><td styleCode="Rrule" align="center" valign="middle">8 </td><td styleCode="Rrule" align="center" valign="middle">(5.2) </td><td styleCode="Rrule" align="center" valign="middle">11<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(6.9) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Sinusitis </td><td styleCode="Rrule" align="center" valign="middle">17 </td><td styleCode="Rrule" align="center" valign="middle">(11.0) </td><td styleCode="Rrule" align="center" valign="middle">18<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(11.3) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Upper Respiratory </td><td styleCode="Rrule" align="justify" valign="middle"> </td><td styleCode="Rrule" align="justify" valign="middle"> </td><td styleCode="Rrule" align="justify" valign="middle"><content styleCode="bold"> </content> </td><td styleCode="Rrule" align="justify" valign="middle"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" align="justify" valign="middle">Tract Infection </td><td styleCode="Rrule" align="center" valign="middle">24 </td><td styleCode="Rrule" align="center" valign="middle">(15.5) </td><td styleCode="Rrule" align="center" valign="middle">21<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(13.2) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5" align="justify" valign="middle"><content styleCode="bold">Urogenital System</content> </td></tr><tr><td styleCode="Lrule Rrule" align="justify" valign="middle">Urinary Tract Infection<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">10 </td><td styleCode="Rrule" align="center" valign="middle">(6.5) </td><td styleCode="Rrule" align="center" valign="middle">7<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">(4.4) </td></tr></tbody></table>
adverse reactions table <table cellspacing="0" cellpadding="0" border="0" width="100%"><colgroup><col width="34.26%"/><col width="17.14%"/><col width="16.12%"/><col width="14.94%"/><col width="17.54%"/></colgroup><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" colspan="5" align="center" valign="middle"><content styleCode="bold">GALLSTONE PREVENTION</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> </td><td styleCode="Rrule" colspan="2" align="center" valign="middle"><content styleCode="bold">Ursodiol </content><content styleCode="bold"/> </td><td styleCode="Rrule" colspan="2" align="center" valign="middle"><content styleCode="bold">Placebo</content> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> </td><td styleCode="Rrule" colspan="2" align="center" valign="middle">600 mg (N = 322) </td><td styleCode="Rrule" colspan="2" align="center" valign="middle">(N = 325) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"> </td><td styleCode="Rrule" align="center" valign="middle">N </td><td styleCode="Rrule" align="center" valign="middle">(%) </td><td styleCode="Rrule" align="center" valign="middle">N </td><td styleCode="Rrule" align="center" valign="middle">(%) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"><content styleCode="bold">Body as a Whole</content> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Fatigue<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">25 </td><td styleCode="Rrule" align="center" valign="middle">(7.8) </td><td styleCode="Rrule" align="center" valign="middle">33 </td><td styleCode="Rrule" align="center" valign="middle">(10.2) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Infection Viral<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">29 </td><td styleCode="Rrule" align="center" valign="middle">(9.0) </td><td styleCode="Rrule" align="center" valign="middle">29 </td><td styleCode="Rrule" align="center" valign="middle">(8.9) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Influenza-like Symptoms<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">21 </td><td styleCode="Rrule" align="center" valign="middle">(6.5) </td><td styleCode="Rrule" align="center" valign="middle">19 </td><td styleCode="Rrule" align="center" valign="middle">(5.8) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"><content styleCode="bold">Digestive System</content> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Abdominal Pain<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">20 </td><td styleCode="Rrule" align="center" valign="middle">(6.2) </td><td styleCode="Rrule" align="center" valign="middle">39 </td><td styleCode="Rrule" align="center" valign="middle">(12.0) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Constipation<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">85 </td><td styleCode="Rrule" align="center" valign="middle">(26.4) </td><td styleCode="Rrule" align="center" valign="middle">72 </td><td styleCode="Rrule" align="center" valign="middle">(22.2) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Diarrhea </td><td styleCode="Rrule" align="center" valign="middle">81 </td><td styleCode="Rrule" align="center" valign="middle">(25.2) </td><td styleCode="Rrule" align="center" valign="middle">68 </td><td styleCode="Rrule" align="center" valign="middle">(20.9) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Flatulence </td><td styleCode="Rrule" align="center" valign="middle">15 </td><td styleCode="Rrule" align="center" valign="middle">(4.7) </td><td styleCode="Rrule" align="center" valign="middle">24 </td><td styleCode="Rrule" align="center" valign="middle">(7.4) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Nausea </td><td styleCode="Rrule" align="center" valign="middle">56 </td><td styleCode="Rrule" align="center" valign="middle">(17.4) </td><td styleCode="Rrule" align="center" valign="middle">43 </td><td styleCode="Rrule" align="center" valign="middle">(13.2) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Vomiting </td><td styleCode="Rrule" align="center" valign="middle">44 </td><td styleCode="Rrule" align="center" valign="middle">(13.7) </td><td styleCode="Rrule" align="center" valign="middle">44 </td><td styleCode="Rrule" align="center" valign="middle">(13.5) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"><content styleCode="bold">Musculoskeletal System</content> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Back Pain </td><td styleCode="Rrule" align="center" valign="middle">38 </td><td styleCode="Rrule" align="center" valign="middle">(11.8) </td><td styleCode="Rrule" align="center" valign="middle">21 </td><td styleCode="Rrule" align="center" valign="middle">(6.5) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Musculoskeletal Pain </td><td styleCode="Rrule" align="center" valign="middle">19 </td><td styleCode="Rrule" align="center" valign="middle">(5.9) </td><td styleCode="Rrule" align="center" valign="middle">15 </td><td styleCode="Rrule" align="center" valign="middle">(4.6) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"><content styleCode="bold">Nervous System</content> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Dizziness </td><td styleCode="Rrule" align="center" valign="middle">53 </td><td styleCode="Rrule" align="center" valign="middle">(16.5) </td><td styleCode="Rrule" align="center" valign="middle">42 </td><td styleCode="Rrule" align="center" valign="middle">(12.9) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Headache </td><td styleCode="Rrule" align="center" valign="middle">80 </td><td styleCode="Rrule" align="center" valign="middle">(24.8) </td><td styleCode="Rrule" align="center" valign="middle">78 </td><td styleCode="Rrule" align="center" valign="middle">(24.0) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"><content styleCode="bold">Respiratory System</content> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Pharyngitis </td><td styleCode="Rrule" align="center" valign="middle">10 </td><td styleCode="Rrule" align="center" valign="middle">(3.1) </td><td styleCode="Rrule" align="center" valign="middle">19 </td><td styleCode="Rrule" align="center" valign="middle">(5.8) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Sinusitis </td><td styleCode="Rrule" align="center" valign="middle">17 </td><td styleCode="Rrule" align="center" valign="middle">(5.3) </td><td styleCode="Rrule" align="center" valign="middle">18 </td><td styleCode="Rrule" align="center" valign="middle">(5.5) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Upper Respiratory </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Tract Infection </td><td styleCode="Rrule" align="center" valign="middle">40 </td><td styleCode="Rrule" align="center" valign="middle">(12.4) </td><td styleCode="Rrule" align="center" valign="middle">35 </td><td styleCode="Rrule" align="center" valign="middle">(10.8) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"><content styleCode="bold">Skin and Appendages</content> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle">Alopecia </td><td styleCode="Rrule" align="center" valign="middle">17 </td><td styleCode="Rrule" align="center" valign="middle">(5.3) </td><td styleCode="Rrule" align="center" valign="middle">8 </td><td styleCode="Rrule" align="center" valign="middle">(2.5) </td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"><content styleCode="bold">Urogenital System</content> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td><td styleCode="Rrule" valign="middle"> </td></tr><tr><td styleCode="Lrule Rrule" valign="middle">Dysmenorrhea<content styleCode="bold"/> </td><td styleCode="Rrule" align="center" valign="middle">18 </td><td styleCode="Rrule" align="center" valign="middle">(5.6) </td><td styleCode="Rrule" align="center" valign="middle">19 </td><td styleCode="Rrule" align="center" valign="middle">(5.8) </td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.