FDA.reportPublic FDA data

FDA label d7fda535-cac7-30ff-e053-2a95a90a6ba9

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)

SPL set ID
91847322-f217-f337-81ca-ef02aca4446b
SPL ID
d7fda535-cac7-30ff-e053-2a95a90a6ba9
Version
4
Effective date
2022-02-14
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:58:23

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: Figure 2 Gallstone Dissolution In Ursodiol and Placebo Patients GALLSTONE DISSOLUTION Ursodiol 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 20 (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) 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 Rrespiratory Tract Infection 24 (15.5) 21 (13.2) Urogenital System Urinary Tract Infection 10 (6.5) 7 (4.4) Figure 3 Gallstone Prevention in Ursodiol and Placebo-Treated Patients 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 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)

adverse reactions table

<table ID="id_78f3f0c7-ba54-4b63-8cea-c0d9c6d5468a" width="429"><caption ID="id_66c8061c-865d-4a24-8e8b-0e2f90ce0e40">Figure 2</caption><col width="44.8%"/><col width="12.8%"/><col width="15.4%"/><col width="12.4%"/><col width="14.7%"/><tfoot ID="id_45eb017f-f329-467d-ba49-b0f81f06c853"><tr><td align="left" colspan="5" styleCode="Botrule" valign="top">Gallstone Dissolution In Ursodiol and Placebo Patients</td></tr></tfoot><tbody><tr ID="id_f9be6e14-232a-4813-863c-cf0e6aa8e70b"><td align="center" colspan="5" styleCode="Lrule Botrule" valign="top"><content styleCode="underline"><content styleCode="bold">GALLSTONE DISSOLUTION</content></content></td></tr><tr ID="id_7eb897c0-4696-49a6-a5da-cf3de88c19f1"><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="center" colspan="2" styleCode="Botrule Rrule" valign="top"><paragraph><content styleCode="underline"><content styleCode="bold">Ursodiol</content></content></paragraph><paragraph>8 - 10 mg/kg/day</paragraph>(N=155) </td><td align="center" colspan="2" styleCode="Lrule Botrule" valign="top"><paragraph><content styleCode="underline"><content styleCode="bold">Placebo</content></content></paragraph><paragraph>(N=159)</paragraph></td></tr><tr ID="id_de514a86-a6da-4c2a-97ae-f32048402291"><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"><content styleCode="underline">N</content></td><td align="center" styleCode="Botrule Rrule" valign="top"><content styleCode="underline">(%)</content></td><td align="center" styleCode="Botrule Rrule" valign="top"><content styleCode="underline">N</content></td><td align="center" styleCode="Lrule Botrule" valign="top"><content styleCode="underline">(%)</content></td></tr><tr ID="id_5bf04b6e-0821-491d-a5d1-a91d9597ac9c"><td align="left" styleCode="Botrule Rrule" valign="top"><content styleCode="underline"><content styleCode="bold">Body as a Whole</content></content></td><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_9420aba9-fdcb-4fe4-b661-c225df510c17"><td align="left" styleCode="Botrule Rrule" valign="top"> Allergy</td><td align="center" styleCode="Botrule Rrule" valign="top">8</td><td align="center" styleCode="Botrule Rrule" valign="top">(5.2)</td><td align="center" styleCode="Botrule Rrule" valign="top">7</td><td align="center" styleCode="Lrule Botrule" valign="top">(4.4)</td></tr><tr ID="id_872bacf1-6766-4db8-9eb7-df8480b77880"><td align="left" styleCode="Botrule Rrule" valign="top"> Chest Pain</td><td align="center" styleCode="Botrule Rrule" valign="top">5</td><td align="center" styleCode="Botrule Rrule" valign="top">(3.2)</td><td align="center" styleCode="Botrule Rrule" valign="top">10</td><td align="center" styleCode="Lrule Botrule" valign="top">(6.3)</td></tr><tr ID="id_b4c86526-1004-4137-ab49-bbc37b7feebe"><td align="left" styleCode="Botrule Rrule" valign="top"> Fatigue</td><td align="center" styleCode="Botrule Rrule" valign="top">7</td><td align="center" styleCode="Botrule Rrule" valign="top">(4.5)</td><td align="center" styleCode="Botrule Rrule" valign="top">8</td><td align="center" styleCode="Lrule Botrule" valign="top">(5.0)</td></tr><tr ID="id_32ce19be-6a9b-4c7c-9df3-65fa7db0bb87"><td align="left" styleCode="Botrule Rrule" valign="top"> Infection Viral</td><td align="center" styleCode="Botrule Rrule" valign="top">20</td><td align="center" styleCode="Botrule Rrule" valign="top">(19.4)</td><td align="center" styleCode="Botrule Rrule" valign="top">41</td><td align="center" styleCode="Lrule Botrule" valign="top">(25.8)</td></tr><tr ID="id_6206ac21-b969-4ede-8bbb-edc07a46466d"><td align="left" styleCode="Botrule Rrule" valign="top"><content styleCode="underline"><content styleCode="bold">Digestive System</content></content></td><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_b2c0d2ae-ef68-4b8c-b8c1-4ced4c1550fe"><td align="left" styleCode="Botrule Rrule" valign="top"> Abdominal Pain</td><td align="center" styleCode="Botrule Rrule" valign="top">67</td><td align="center" styleCode="Botrule Rrule" valign="top">(43.2)</td><td align="center" styleCode="Botrule Rrule" valign="top">70</td><td align="center" styleCode="Lrule Botrule" valign="top">(44.0)</td></tr><tr ID="id_b8e48baf-7754-4254-988e-0d2dd6507282"><td align="left" styleCode="Botrule Rrule" valign="top"> Cholecystitis</td><td align="center" styleCode="Botrule Rrule" valign="top">8</td><td align="center" styleCode="Botrule Rrule" valign="top">(5.2)</td><td align="center" styleCode="Botrule Rrule" valign="top">7</td><td align="center" styleCode="Lrule Botrule" valign="top">(4.4)</td></tr><tr ID="id_1b2aa822-e5e5-4b8c-b94a-7f1f9afac59c"><td align="left" styleCode="Botrule Rrule" valign="top"> Constipation</td><td align="center" styleCode="Botrule Rrule" valign="top">15 </td><td align="center" styleCode="Botrule Rrule" valign="top">(9.7)</td><td align="center" styleCode="Botrule Rrule" valign="top">14 </td><td align="center" styleCode="Lrule Botrule" valign="top">(8.8)</td></tr><tr ID="id_b87ceab7-fa32-43a9-825f-476524c0f381"><td align="left" styleCode="Botrule Rrule" valign="top"> Diarrhea</td><td align="center" styleCode="Botrule Rrule" valign="top">42 </td><td align="center" styleCode="Botrule Rrule" valign="top">(27.1)</td><td align="center" styleCode="Botrule Rrule" valign="top">34 </td><td align="center" styleCode="Lrule Botrule" valign="top">(21.4)</td></tr><tr ID="id_b11b0962-81bc-405e-8993-5eda321f82b9"><td align="left" styleCode="Botrule Rrule" valign="top"> Flatulence</td><td align="center" styleCode="Botrule Rrule" valign="top">12 </td><td align="center" styleCode="Botrule Rrule" valign="top">(7.7)</td><td align="center" styleCode="Botrule Rrule" valign="top">12 </td><td align="center" styleCode="Lrule Botrule" valign="top">(7.5)</td></tr><tr ID="id_fceec497-0a91-49b9-b875-e115787b0768"><td align="left" styleCode="Botrule Rrule" valign="top"> Gastrointestinal Disorder</td><td align="center" styleCode="Botrule Rrule" valign="top">6 </td><td align="center" styleCode="Botrule Rrule" valign="top">(3.9)</td><td align="center" styleCode="Botrule Rrule" valign="top">8 </td><td align="center" styleCode="Lrule Botrule" valign="top">(5.0)</td></tr><tr ID="id_995c00d1-3f3f-4940-b566-3105b9e5b6f5"><td align="left" styleCode="Botrule Rrule" valign="top"> Nausea</td><td align="center" styleCode="Botrule Rrule" valign="top">22 </td><td align="center" styleCode="Botrule Rrule" valign="top">(14.2)</td><td align="center" styleCode="Botrule Rrule" valign="top">27 </td><td align="center" styleCode="Lrule Botrule" valign="top">(17.0)</td></tr><tr ID="id_5e31cbec-fa74-4238-92a5-3f5e1d9ee296"><td align="left" styleCode="Botrule Rrule" valign="top"> Vomiting</td><td align="center" styleCode="Botrule Rrule" valign="top">15 </td><td align="center" styleCode="Botrule Rrule" valign="top">(9.7)</td><td align="center" styleCode="Botrule Rrule" valign="top">11 </td><td align="center" styleCode="Lrule Botrule" valign="top">(6.9)</td></tr><tr ID="id_50716187-9b8a-4774-a848-3a7288c5f0e3"><td align="left" styleCode="Botrule Rrule" valign="top"><content styleCode="bold"><content styleCode="underline">Musculoskeletal System</content></content></td><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_98bf7310-c4ff-4381-b6e3-44ff04c683ff"><td align="left" styleCode="Botrule Rrule" valign="top"> Arthralgia</td><td align="center" styleCode="Botrule Rrule" valign="top">12 </td><td align="center" styleCode="Botrule Rrule" valign="top">(7.7)</td><td align="center" styleCode="Botrule Rrule" valign="top">24 </td><td align="center" styleCode="Lrule Botrule" valign="top">(15.1)</td></tr><tr ID="id_6160300b-beb8-442c-91da-19e0a4dcb274"><td align="left" styleCode="Botrule Rrule" valign="top"> Arthritis</td><td align="center" styleCode="Botrule Rrule" valign="top">9 </td><td align="center" styleCode="Botrule Rrule" valign="top">(5.8)</td><td align="center" styleCode="Botrule Rrule" valign="top">4 </td><td align="center" styleCode="Lrule Botrule" valign="top">(2.5)</td></tr><tr ID="id_bd4cc1ac-5d27-4c03-88a1-9ee0ad96b9b9"><td align="left" styleCode="Botrule Rrule" valign="top"> Back Pain</td><td align="center" styleCode="Botrule Rrule" valign="top">11 </td><td align="center" styleCode="Botrule Rrule" valign="top"> (7.1)</td><td align="center" styleCode="Botrule Rrule" valign="top">18 </td><td align="center" styleCode="Lrule Botrule" valign="top">(11.3)</td></tr><tr ID="id_1081049e-e8bc-46f5-82b6-75a57630643d"><td align="left" styleCode="Botrule Rrule" valign="top"> Myalgia</td><td align="center" styleCode="Botrule Rrule" valign="top">9 </td><td align="center" styleCode="Botrule Rrule" valign="top">(5.8)</td><td align="center" styleCode="Botrule Rrule" valign="top">9 </td><td align="center" styleCode="Lrule Botrule" valign="top">(5.7)</td></tr><tr ID="id_628a89c3-ac92-405d-ae48-c841b65fee7b"><td align="left" styleCode="Botrule Rrule" valign="top"><content styleCode="bold"><content styleCode="underline">Nervous System</content></content></td><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_efdffad4-0e8c-412b-9d59-e830d326e81b"><td align="left" styleCode="Botrule Rrule" valign="top"> Headache</td><td align="center" styleCode="Botrule Rrule" valign="top">28 </td><td align="center" styleCode="Botrule Rrule" valign="top">(18.1)</td><td align="center" styleCode="Botrule Rrule" valign="top">34 </td><td align="center" styleCode="Lrule Botrule" valign="top">(21.4)</td></tr><tr ID="id_2a472f48-5419-40a1-880f-5afe49a07574"><td align="left" styleCode="Botrule Rrule" valign="top"> Insomnia</td><td align="center" styleCode="Botrule Rrule" valign="top">3 </td><td align="center" styleCode="Botrule Rrule" valign="top">(1.9)</td><td align="center" styleCode="Botrule Rrule" valign="top">8 </td><td align="center" styleCode="Lrule Botrule" valign="top"> (5.0)</td></tr><tr ID="id_0ce79374-73ce-49de-9d74-eca7db90f562"><td align="left" styleCode="Botrule Rrule" valign="top"><content styleCode="bold"><content styleCode="underline">Respiratory System</content></content></td><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_b6d2c0ff-8fe7-4d8f-8fce-b336f3970849"><td align="left" styleCode="Botrule Rrule" valign="top"> Bronchitis</td><td align="center" styleCode="Botrule Rrule" valign="top">10 </td><td align="center" styleCode="Botrule Rrule" valign="top">(6.5)</td><td align="center" styleCode="Botrule Rrule" valign="top">6 </td><td align="center" styleCode="Lrule Botrule" valign="top">(3.8)</td></tr><tr ID="id_823c31ad-a2a6-4ffe-b6f7-26443832e730"><td align="left" styleCode="Botrule Rrule" valign="top"> Coughing</td><td align="center" styleCode="Botrule Rrule" valign="top">11 </td><td align="center" styleCode="Botrule Rrule" valign="top">(7.1)</td><td align="center" styleCode="Botrule Rrule" valign="top">7 </td><td align="center" styleCode="Lrule Botrule" valign="top">(4.4)</td></tr><tr ID="id_f21853f6-23a4-4e7f-8b1b-172fc5e189db"><td align="left" styleCode="Botrule Rrule" valign="top"> Pharyngitis</td><td align="center" styleCode="Botrule Rrule" valign="top">13 </td><td align="center" styleCode="Botrule Rrule" valign="top">(8.4)</td><td align="center" styleCode="Botrule Rrule" valign="top">5 </td><td align="center" styleCode="Lrule Botrule" valign="top">(3.1)</td></tr><tr ID="id_94d30c5f-e19f-4809-abd6-18a17afc1755"><td align="left" styleCode="Botrule Rrule" valign="top"> Rhinitis</td><td align="center" styleCode="Botrule Rrule" valign="top">8 </td><td align="center" styleCode="Botrule Rrule" valign="top"> (5.2)</td><td align="center" styleCode="Botrule Rrule" valign="top">11 </td><td align="center" styleCode="Lrule Botrule" valign="top">(6.9)</td></tr><tr ID="id_c5459380-2430-45b6-a33f-6394a8d6f825"><td align="left" styleCode="Botrule Rrule" valign="top"> Sinusitis</td><td align="center" styleCode="Botrule Rrule" valign="top">17 </td><td align="center" styleCode="Botrule Rrule" valign="top">(11.0)</td><td align="center" styleCode="Botrule Rrule" valign="top">18 </td><td align="center" styleCode="Lrule Botrule" valign="top">(11.3)</td></tr><tr ID="id_19da1ac5-bf05-46f5-a1ad-aded27124acf"><td align="left" styleCode="Botrule Rrule" valign="top"> Upper Rrespiratory Tract Infection</td><td align="center" styleCode="Botrule Rrule" valign="top">24 </td><td align="center" styleCode="Botrule Rrule" valign="top">(15.5)</td><td align="center" styleCode="Botrule Rrule" valign="top">21 </td><td align="center" styleCode="Lrule Botrule" valign="top">(13.2)</td></tr><tr ID="id_6958eee8-0b5d-40d2-a90b-35ee7338ce2d"><td align="left" styleCode="Botrule Rrule" valign="top"><content styleCode="bold"><content styleCode="underline">Urogenital System</content></content></td><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_202f1ffd-1af8-4b13-be0b-a25495a10bd8"><td align="left" styleCode="Botrule Rrule" valign="top"> Urinary Tract Infection</td><td align="center" styleCode="Botrule Rrule" valign="top">10 </td><td align="center" styleCode="Botrule Rrule" valign="top">(6.5)</td><td align="center" styleCode="Botrule Rrule" valign="top">7 </td><td align="center" styleCode="Lrule Botrule" valign="top">(4.4)</td></tr><tr ID="id_7c891697-cd25-45d9-8d84-6dd11d5f6c66"><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_e97279c2-f304-4ed9-8666-71b57c56af58"><td align="left" styleCode="Rrule" valign="top"/><td align="left" styleCode="Rrule" valign="top"/><td align="left" styleCode="Rrule" valign="top"/><td align="left" styleCode="Rrule" valign="top"/><td align="left" styleCode="Botrule" valign="top"/></tr></tbody></table>

adverse reactions table

<table ID="id_b92428e6-a07f-43af-93da-545042b189b2" width="427"><caption ID="id_cbe0adc3-f60d-48fb-8386-b165e8c3f45b">Figure 3</caption><col width="42.4%"/><col width="14.1%"/><col width="16.6%"/><col width="14.1%"/><col width="12.9%"/><tfoot ID="id_414aa32d-618f-4c25-882f-372db2ad55a8"><tr><td align="left" colspan="5" styleCode="Botrule" valign="top">Gallstone Prevention in Ursodiol and Placebo-Treated Patients</td></tr></tfoot><tbody><tr ID="id_c5dc4f2f-70cb-49e8-b930-8cc96c856371"><td align="center" colspan="5" styleCode="Lrule Botrule" valign="top"><content styleCode="underline"><content styleCode="bold">GALLSTONE PREVENTION</content></content></td></tr><tr ID="id_91ec1e01-6f3f-469d-bd88-53c89a4a4f22"><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="center" colspan="2" styleCode="Botrule Rrule" valign="top"><paragraph><content styleCode="underline"><content styleCode="bold">Ursodiol</content></content></paragraph><paragraph>600 mg</paragraph><paragraph>(N=322)</paragraph></td><td align="center" colspan="2" styleCode="Lrule Botrule" valign="top"><paragraph><content styleCode="bold"><content styleCode="underline">Placebo</content></content></paragraph><paragraph>(N=325)</paragraph></td></tr><tr ID="id_085a5497-9048-4377-a39a-b80a4195081b"><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"><content styleCode="underline">N</content></td><td align="center" styleCode="Botrule Rrule" valign="top"><content styleCode="underline">(%)</content></td><td align="center" styleCode="Botrule Rrule" valign="top"><content styleCode="underline">N</content></td><td align="center" styleCode="Lrule Botrule" valign="top"><content styleCode="underline">(%)</content></td></tr><tr ID="id_a00f5357-ece7-46ec-a71d-8295a598c1cb"><td align="left" styleCode="Botrule Rrule" valign="top"><content styleCode="bold"><content styleCode="underline">Body as a Whole</content></content></td><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_351dd204-e4fb-4cb6-8c52-29748e499e1d"><td align="left" styleCode="Botrule Rrule" valign="top"> Fatigue</td><td align="center" styleCode="Botrule Rrule" valign="top">25 </td><td align="center" styleCode="Botrule Rrule" valign="top">(7.8)</td><td align="center" styleCode="Botrule Rrule" valign="top">33 </td><td align="center" styleCode="Lrule Botrule" valign="top">(10.2)</td></tr><tr ID="id_b6515f0d-fd7c-45f0-82d3-2caeced43717"><td align="left" styleCode="Botrule Rrule" valign="top"> Infection Viral</td><td align="center" styleCode="Botrule Rrule" valign="top">29 </td><td align="center" styleCode="Botrule Rrule" valign="top">(9.0)</td><td align="center" styleCode="Botrule Rrule" valign="top">29 </td><td align="center" styleCode="Lrule Botrule" valign="top">(8.9)</td></tr><tr ID="id_6445b217-1028-4852-8513-2f5ece6cfebd"><td align="left" styleCode="Botrule Rrule" valign="top"> Influenza-like Symptoms</td><td align="center" styleCode="Botrule Rrule" valign="top">21 </td><td align="center" styleCode="Botrule Rrule" valign="top">(6.5)</td><td align="center" styleCode="Botrule Rrule" valign="top">19 </td><td align="center" styleCode="Lrule Botrule" valign="top">(5.8)</td></tr><tr ID="id_ee68f2e9-b0e3-48ce-866e-db7c48e4a8aa"><td align="left" styleCode="Botrule Rrule" valign="top"><content styleCode="bold"><content styleCode="underline">Digestive System</content></content></td><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_a7762b5c-4c4e-4122-998a-71cb75840491"><td align="left" styleCode="Botrule Rrule" valign="top"> Abdominal Pain</td><td align="center" styleCode="Botrule Rrule" valign="top">20 </td><td align="center" styleCode="Botrule Rrule" valign="top">(6.2)</td><td align="center" styleCode="Botrule Rrule" valign="top">39 </td><td align="center" styleCode="Lrule Botrule" valign="top">(12.0)</td></tr><tr ID="id_7b53020e-fd2d-4fb4-b585-cc3b1d120651"><td align="left" styleCode="Botrule Rrule" valign="top"> Constipation</td><td align="center" styleCode="Botrule Rrule" valign="top">85 </td><td align="center" styleCode="Botrule Rrule" valign="top">(26.4)</td><td align="center" styleCode="Botrule Rrule" valign="top">72 </td><td align="center" styleCode="Lrule Botrule" valign="top">(22.2)</td></tr><tr ID="id_6b60cfff-8b6f-4602-bfcd-775ac545708a"><td align="left" styleCode="Botrule Rrule" valign="top"> Diarrhea</td><td align="center" styleCode="Botrule Rrule" valign="top">81 </td><td align="center" styleCode="Botrule Rrule" valign="top">(25.2)</td><td align="center" styleCode="Botrule Rrule" valign="top">68 </td><td align="center" styleCode="Lrule Botrule" valign="top">(20.9)</td></tr><tr ID="id_b00dbb16-8222-43a2-a93c-8b2ed1ee8553"><td align="left" styleCode="Botrule Rrule" valign="top"> Flatulence</td><td align="center" styleCode="Botrule Rrule" valign="top">15 </td><td align="center" styleCode="Botrule Rrule" valign="top">(4.7)</td><td align="center" styleCode="Botrule Rrule" valign="top">24 </td><td align="center" styleCode="Lrule Botrule" valign="top">(7.4)</td></tr><tr ID="id_bc74ff06-dc78-4e26-b42f-7bbc3761c5ad"><td align="left" styleCode="Botrule Rrule" valign="top"> Nausea</td><td align="center" styleCode="Botrule Rrule" valign="top">56 </td><td align="center" styleCode="Botrule Rrule" valign="top">(17.4)</td><td align="center" styleCode="Botrule Rrule" valign="top">43 </td><td align="center" styleCode="Lrule Botrule" valign="top">(13.2)</td></tr><tr ID="id_45559a6c-8fa4-4cb6-99e2-7b014c17edb2"><td align="left" styleCode="Botrule Rrule" valign="top"> Vomiting </td><td align="center" styleCode="Botrule Rrule" valign="top">44 </td><td align="center" styleCode="Botrule Rrule" valign="top">(13.7)</td><td align="center" styleCode="Botrule Rrule" valign="top">44 </td><td align="center" styleCode="Lrule Botrule" valign="top">(13.5)</td></tr><tr ID="id_598362f6-6da1-4af3-927d-8306244fcc55"><td align="left" styleCode="Botrule Rrule" valign="top"><content styleCode="bold"><content styleCode="underline">Musculoskeletal System</content></content></td><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Botrule Rrule" valign="top"/><td align="left" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_72f16331-5e49-49f3-8e25-febb20e50ea5"><td align="left" styleCode="Botrule Rrule" valign="top"> Back Pain</td><td align="center" styleCode="Botrule Rrule" valign="top">38 </td><td align="center" styleCode="Botrule Rrule" valign="top">(11.8)</td><td align="center" styleCode="Botrule Rrule" valign="top">21 </td><td align="center" styleCode="Lrule Botrule" valign="top">(6.5)</td></tr><tr ID="id_ca5afc71-c6cc-4058-a146-75ea3e96e17e"><td align="left" styleCode="Botrule Rrule" valign="top"> Musculoskeletal Pain</td><td align="center" styleCode="Botrule Rrule" valign="top">19 </td><td align="center" styleCode="Botrule Rrule" valign="top">(5.9)</td><td align="center" styleCode="Botrule Rrule" valign="top">15 </td><td align="center" styleCode="Lrule Botrule" valign="top">(4.6)</td></tr><tr ID="id_62237b14-8d15-4011-aeb9-f90c246b753b"><td align="left" styleCode="Botrule Rrule" valign="top"><content styleCode="bold"><content styleCode="underline">Nervous System</content></content></td><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_374ce23a-a8b7-40fb-8957-724e1b1bed52"><td align="left" styleCode="Botrule Rrule" valign="top"> Dizziness </td><td align="center" styleCode="Botrule Rrule" valign="top">53 </td><td align="center" styleCode="Botrule Rrule" valign="top">(16.5)</td><td align="center" styleCode="Botrule Rrule" valign="top">42 </td><td align="center" styleCode="Lrule Botrule" valign="top">(12.9)</td></tr><tr ID="id_eb1b990d-ae44-47da-a46e-d467d7bdbcdf"><td align="left" styleCode="Botrule Rrule" valign="top"> Headache</td><td align="center" styleCode="Botrule Rrule" valign="top">80 </td><td align="center" styleCode="Botrule Rrule" valign="top">(24.8)</td><td align="center" styleCode="Botrule Rrule" valign="top">78 </td><td align="center" styleCode="Lrule Botrule" valign="top">(24.0)</td></tr><tr ID="id_9868bfd2-d5a8-406b-b56b-26b8713baa53"><td align="left" styleCode="Botrule Rrule" valign="top"><content styleCode="bold"><content styleCode="underline">Respiratory System</content></content></td><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_4c429b16-3390-4299-9107-c1aa732ceb15"><td align="left" styleCode="Botrule Rrule" valign="top"> Pharyngitis</td><td align="center" styleCode="Botrule Rrule" valign="top">10 </td><td align="center" styleCode="Botrule Rrule" valign="top">(3.1)</td><td align="center" styleCode="Botrule Rrule" valign="top">19 </td><td align="center" styleCode="Lrule Botrule" valign="top">(5.8)</td></tr><tr ID="id_28cf3313-92b7-4e88-871c-c39484c9d4be"><td align="left" styleCode="Botrule Rrule" valign="top"> Sinusitis</td><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_dd374a3a-ccbc-4623-8223-7850cfe10259"><td align="left" styleCode="Botrule Rrule" valign="top"> Upper Respiratory Tract Infection</td><td align="center" styleCode="Botrule Rrule" valign="top">40 </td><td align="center" styleCode="Botrule Rrule" valign="top">(12.4)</td><td align="center" styleCode="Botrule Rrule" valign="top">35 </td><td align="center" styleCode="Lrule Botrule" valign="top">(10.8)</td></tr><tr ID="id_edba8d8c-dc2f-45ff-bc7f-86cfbfd8061d"><td align="left" styleCode="Botrule Rrule" valign="top"><content styleCode="bold"><content styleCode="underline">Skin and Appendages</content></content></td><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_f26036b0-1a9f-489e-bf68-5d4cc3a777d9"><td align="left" styleCode="Botrule Rrule" valign="top"> Alopecia</td><td align="center" styleCode="Botrule Rrule" valign="top">17 </td><td align="center" styleCode="Botrule Rrule" valign="top">(5.3)</td><td align="center" styleCode="Botrule Rrule" valign="top">8 </td><td align="center" styleCode="Lrule Botrule" valign="top">(2.5)</td></tr><tr ID="id_65671bad-18f5-4ac1-a383-ab060950a81e"><td align="left" styleCode="Botrule Rrule" valign="top"><content styleCode="bold"><content styleCode="underline">Urogenital System</content></content></td><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Botrule Rrule" valign="top"/><td align="center" styleCode="Lrule Botrule" valign="top"/></tr><tr ID="id_811bf3eb-618c-441d-a542-b4a720fd6e83"><td align="left" styleCode="Rrule" valign="top"> Dysmenorrhea</td><td align="center" styleCode="Rrule" valign="top">18 </td><td align="center" styleCode="Rrule" valign="top">(5.6)</td><td align="center" styleCode="Rrule" valign="top">19 </td><td align="center" styleCode="Botrule" valign="top">(5.8)</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.