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FDA label 8ccf07f5-7899-76da-e053-2a95a90a0090

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SPL set ID
1fc89d7b-2457-3ce1-6d10-c6dc7ce9f856
SPL ID
8ccf07f5-7899-76da-e053-2a95a90a0090
Version
9
Effective date
2019-07-03
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 05:59:46

Adverse reactions cross-check#

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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: 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 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 Dyspepsia 42 26 (27.1) (16.8) 34 18 (21.4) (7.5) 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 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 AvKARE, Inc. at 1-855-361-3993; email drugsafety@avkare.com ; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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">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="Botrule Lrule"> <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"/> <td align="center" colspan="2" styleCode="Botrule Rrule"> <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="Botrule Lrule"> <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"/> <td align="center" styleCode="Botrule Rrule"> <content styleCode="underline">N</content> </td> <td align="center" styleCode="Botrule Rrule"> <content styleCode="underline">(%)</content> </td> <td align="center" styleCode="Botrule Rrule"> <content styleCode="underline">N</content> </td> <td align="center" styleCode="Botrule Lrule"> <content styleCode="underline">(%)</content> </td> </tr> <tr ID="id_5bf04b6e-0821-491d-a5d1-a91d9597ac9c"> <td align="left" styleCode="Botrule Rrule"> <content styleCode="underline"> <content styleCode="bold">Body as a Whole</content> </content> </td> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Lrule"/> </tr> <tr ID="id_9420aba9-fdcb-4fe4-b661-c225df510c17"> <td align="left" styleCode="Botrule Rrule">Allergy</td> <td align="center" styleCode="Botrule Rrule">8</td> <td align="center" styleCode="Botrule Rrule">(5.2)</td> <td align="center" styleCode="Botrule Rrule">7</td> <td align="center" styleCode="Botrule Lrule">(4.4)</td> </tr> <tr ID="id_872bacf1-6766-4db8-9eb7-df8480b77880"> <td align="left" styleCode="Botrule Rrule">Chest Pain</td> <td align="center" styleCode="Botrule Rrule">5</td> <td align="center" styleCode="Botrule Rrule">(3.2)</td> <td align="center" styleCode="Botrule Rrule">10</td> <td align="center" styleCode="Botrule Lrule">(6.3)</td> </tr> <tr ID="id_b4c86526-1004-4137-ab49-bbc37b7feebe"> <td align="left" styleCode="Botrule Rrule">Fatigue</td> <td align="center" styleCode="Botrule Rrule">7</td> <td align="center" styleCode="Botrule Rrule">(4.5)</td> <td align="center" styleCode="Botrule Rrule">8</td> <td align="center" styleCode="Botrule Lrule">(5.0)</td> </tr> <tr ID="id_32ce19be-6a9b-4c7c-9df3-65fa7db0bb87"> <td align="left" styleCode="Botrule Rrule">Infection Viral</td> <td align="center" styleCode="Botrule Rrule">30</td> <td align="center" styleCode="Botrule Rrule">(19.4)</td> <td align="center" styleCode="Botrule Rrule">41</td> <td align="center" styleCode="Botrule Lrule">(25.8)</td> </tr> <tr ID="id_6206ac21-b969-4ede-8bbb-edc07a46466d"> <td align="left" styleCode="Botrule Rrule"> <content styleCode="underline"> <content styleCode="bold">Digestive System</content> </content> </td> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Lrule"/> </tr> <tr ID="id_b2c0d2ae-ef68-4b8c-b8c1-4ced4c1550fe"> <td align="left" styleCode="Botrule Rrule">Abdominal Pain</td> <td align="center" styleCode="Botrule Rrule">67</td> <td align="center" styleCode="Botrule Rrule">(43.2)</td> <td align="center" styleCode="Botrule Rrule">70</td> <td align="center" styleCode="Botrule Lrule">(44.0)</td> </tr> <tr ID="id_b8e48baf-7754-4254-988e-0d2dd6507282"> <td align="left" styleCode="Botrule Rrule">Cholecystitis</td> <td align="center" styleCode="Botrule Rrule">8</td> <td align="center" styleCode="Botrule Rrule">(5.2)</td> <td align="center" styleCode="Botrule Rrule">7</td> <td align="center" styleCode="Botrule Lrule">(4.4)</td> </tr> <tr ID="id_1b2aa822-e5e5-4b8c-b94a-7f1f9afac59c"> <td align="left" styleCode="Botrule Rrule">Constipation</td> <td align="center" styleCode="Botrule Rrule">15 </td> <td align="center" styleCode="Botrule Rrule">(9.7)</td> <td align="center" styleCode="Botrule Rrule">14 </td> <td align="center" styleCode="Botrule Lrule">(8.8)</td> </tr> <tr ID="id_b87ceab7-fa32-43a9-825f-476524c0f381"> <td align="left" styleCode="Botrule Rrule">Diarrhea Dyspepsia </td> <td align="center" styleCode="Botrule Rrule"> <paragraph>42 26 </paragraph> </td> <td align="center" styleCode="Botrule Rrule">(27.1) (16.8) </td> <td align="center" styleCode="Botrule Rrule">34 18 </td> <td align="center" styleCode="Botrule Lrule">(21.4) (7.5) </td> </tr> <tr ID="id_b11b0962-81bc-405e-8993-5eda321f82b9"> <td align="left" styleCode="Botrule Rrule">Flatulence</td> <td align="center" styleCode="Botrule Rrule">12 </td> <td align="center" styleCode="Botrule Rrule">(7.7)</td> <td align="center" styleCode="Botrule Rrule">12 </td> <td align="center" styleCode="Botrule Lrule">(7.5)</td> </tr> <tr ID="id_fceec497-0a91-49b9-b875-e115787b0768"> <td align="left" styleCode="Botrule Rrule">Gastrointestinal Disorder</td> <td align="center" styleCode="Botrule Rrule">6 </td> <td align="center" styleCode="Botrule Rrule">(3.9)</td> <td align="center" styleCode="Botrule Rrule">8 </td> <td align="center" styleCode="Botrule Lrule">(5.0)</td> </tr> <tr ID="id_995c00d1-3f3f-4940-b566-3105b9e5b6f5"> <td align="left" styleCode="Botrule Rrule">Nausea</td> <td align="center" styleCode="Botrule Rrule">22 </td> <td align="center" styleCode="Botrule Rrule">(14.2)</td> <td align="center" styleCode="Botrule Rrule">27 </td> <td align="center" styleCode="Botrule Lrule">(17.0)</td> </tr> <tr ID="id_5e31cbec-fa74-4238-92a5-3f5e1d9ee296"> <td align="left" styleCode="Botrule Rrule">Vomiting</td> <td align="center" styleCode="Botrule Rrule">15 </td> <td align="center" styleCode="Botrule Rrule">(9.7)</td> <td align="center" styleCode="Botrule Rrule">11 </td> <td align="center" styleCode="Botrule Lrule">(6.9)</td> </tr> <tr ID="id_50716187-9b8a-4774-a848-3a7288c5f0e3"> <td align="left" styleCode="Botrule Rrule"> <content styleCode="bold"> <content styleCode="underline">Musculoskeletal System</content> </content> </td> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Lrule"/> </tr> <tr ID="id_98bf7310-c4ff-4381-b6e3-44ff04c683ff"> <td align="left" styleCode="Botrule Rrule">Arthralgia</td> <td align="center" styleCode="Botrule Rrule">12 </td> <td align="center" styleCode="Botrule Rrule">(7.7)</td> <td align="center" styleCode="Botrule Rrule">24 </td> <td align="center" styleCode="Botrule Lrule">(15.1)</td> </tr> <tr ID="id_6160300b-beb8-442c-91da-19e0a4dcb274"> <td align="left" styleCode="Botrule Rrule">Arthritis</td> <td align="center" styleCode="Botrule Rrule">9 </td> <td align="center" styleCode="Botrule Rrule">(5.8)</td> <td align="center" styleCode="Botrule Rrule">4 </td> <td align="center" styleCode="Botrule Lrule">(2.5)</td> </tr> <tr ID="id_bd4cc1ac-5d27-4c03-88a1-9ee0ad96b9b9"> <td align="left" styleCode="Botrule Rrule">Back Pain</td> <td align="center" styleCode="Botrule Rrule">11 </td> <td align="center" styleCode="Botrule Rrule">(7.1)</td> <td align="center" styleCode="Botrule Rrule">18 </td> <td align="center" styleCode="Botrule Lrule">(11.3)</td> </tr> <tr ID="id_1081049e-e8bc-46f5-82b6-75a57630643d"> <td align="left" styleCode="Botrule Rrule">Myalgia</td> <td align="center" styleCode="Botrule Rrule">9 </td> <td align="center" styleCode="Botrule Rrule">(5.8)</td> <td align="center" styleCode="Botrule Rrule">9 </td> <td align="center" styleCode="Botrule Lrule">(5.7)</td> </tr> <tr ID="id_628a89c3-ac92-405d-ae48-c841b65fee7b"> <td align="left" styleCode="Botrule Rrule"> <content styleCode="bold"> <content styleCode="underline">Nervous System</content> </content> </td> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Lrule"/> </tr> <tr ID="id_efdffad4-0e8c-412b-9d59-e830d326e81b"> <td align="left" styleCode="Botrule Rrule">Headache</td> <td align="center" styleCode="Botrule Rrule">28 </td> <td align="center" styleCode="Botrule Rrule">(18.1)</td> <td align="center" styleCode="Botrule Rrule">34 </td> <td align="center" styleCode="Botrule Lrule">(21.4)</td> </tr> <tr ID="id_2a472f48-5419-40a1-880f-5afe49a07574"> <td align="left" styleCode="Botrule Rrule">Insomnia</td> <td align="center" styleCode="Botrule Rrule">3 </td> <td align="center" styleCode="Botrule Rrule">(1.9)</td> <td align="center" styleCode="Botrule Rrule">8 </td> <td align="center" styleCode="Botrule Lrule">(5.0)</td> </tr> <tr ID="id_0ce79374-73ce-49de-9d74-eca7db90f562"> <td align="left" styleCode="Botrule Rrule"> <content styleCode="bold"> <content styleCode="underline">Respiratory System</content> </content> </td> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Lrule"/> </tr> <tr ID="id_b6d2c0ff-8fe7-4d8f-8fce-b336f3970849"> <td align="left" styleCode="Botrule Rrule">Bronchitis</td> <td align="center" styleCode="Botrule Rrule">10 </td> <td align="center" styleCode="Botrule Rrule">(6.5)</td> <td align="center" styleCode="Botrule Rrule">6 </td> <td align="center" styleCode="Botrule Lrule">(3.8)</td> </tr> <tr ID="id_823c31ad-a2a6-4ffe-b6f7-26443832e730"> <td align="left" styleCode="Botrule Rrule">Coughing</td> <td align="center" styleCode="Botrule Rrule">11 </td> <td align="center" styleCode="Botrule Rrule">(7.1)</td> <td align="center" styleCode="Botrule Rrule">7 </td> <td align="center" styleCode="Botrule Lrule">(4.4)</td> </tr> <tr ID="id_f21853f6-23a4-4e7f-8b1b-172fc5e189db"> <td align="left" styleCode="Botrule Rrule">Pharyngitis</td> <td align="center" styleCode="Botrule Rrule">13 </td> <td align="center" styleCode="Botrule Rrule">(8.4)</td> <td align="center" styleCode="Botrule Rrule">5 </td> <td align="center" styleCode="Botrule Lrule">(3.1)</td> </tr> <tr ID="id_94d30c5f-e19f-4809-abd6-18a17afc1755"> <td align="left" styleCode="Botrule Rrule">Rhinitis</td> <td align="center" styleCode="Botrule Rrule">8 </td> <td align="center" styleCode="Botrule Rrule">(5.2)</td> <td align="center" styleCode="Botrule Rrule">11 </td> <td align="center" styleCode="Botrule Lrule">(6.9)</td> </tr> <tr ID="id_c5459380-2430-45b6-a33f-6394a8d6f825"> <td align="left" styleCode="Botrule Rrule">Sinusitis</td> <td align="center" styleCode="Botrule Rrule">17 </td> <td align="center" styleCode="Botrule Rrule">(11.0)</td> <td align="center" styleCode="Botrule Rrule">18 </td> <td align="center" styleCode="Botrule Lrule">(11.3)</td> </tr> <tr ID="id_19da1ac5-bf05-46f5-a1ad-aded27124acf"> <td align="left" styleCode="Botrule Rrule">Upper Rrespiratory Tract Infection</td> <td align="center" styleCode="Botrule Rrule">24 </td> <td align="center" styleCode="Botrule Rrule">(15.5)</td> <td align="center" styleCode="Botrule Rrule">21 </td> <td align="center" styleCode="Botrule Lrule">(13.2)</td> </tr> <tr ID="id_6958eee8-0b5d-40d2-a90b-35ee7338ce2d"> <td align="left" styleCode="Botrule Rrule"> <content styleCode="bold"> <content styleCode="underline">Urogenital System</content> </content> </td> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Lrule"/> </tr> <tr ID="id_202f1ffd-1af8-4b13-be0b-a25495a10bd8"> <td align="left" styleCode="Botrule Rrule">Urinary Tract Infection</td> <td align="center" styleCode="Botrule Rrule">10 </td> <td align="center" styleCode="Botrule Rrule">(6.5)</td> <td align="center" styleCode="Botrule Rrule">7 </td> <td align="center" styleCode="Botrule Lrule">(4.4)</td> </tr> <tr ID="id_7c891697-cd25-45d9-8d84-6dd11d5f6c66"> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Lrule"/> </tr> <tr ID="id_e97279c2-f304-4ed9-8666-71b57c56af58"> <td align="left" styleCode="Rrule"/> <td align="left" styleCode="Rrule"/> <td align="left" styleCode="Rrule"/> <td align="left" styleCode="Rrule"/> <td align="left" styleCode="Botrule"/> </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">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="Botrule Lrule"> <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"/> <td align="center" colspan="2" styleCode="Botrule Rrule"> <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="Botrule Lrule"> <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"/> <td align="center" styleCode="Botrule Rrule"> <content styleCode="underline">N</content> </td> <td align="center" styleCode="Botrule Rrule"> <content styleCode="underline">(%)</content> </td> <td align="center" styleCode="Botrule Rrule"> <content styleCode="underline">N</content> </td> <td align="center" styleCode="Botrule Lrule"> <content styleCode="underline">(%)</content> </td> </tr> <tr ID="id_a00f5357-ece7-46ec-a71d-8295a598c1cb"> <td align="left" styleCode="Botrule Rrule"> <content styleCode="bold"> <content styleCode="underline">Body as a Whole</content> </content> </td> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Lrule"/> </tr> <tr ID="id_351dd204-e4fb-4cb6-8c52-29748e499e1d"> <td align="left" styleCode="Botrule Rrule">Fatigue</td> <td align="center" styleCode="Botrule Rrule">25 </td> <td align="center" styleCode="Botrule Rrule">(7.8)</td> <td align="center" styleCode="Botrule Rrule">33 </td> <td align="center" styleCode="Botrule Lrule">(10.2)</td> </tr> <tr ID="id_b6515f0d-fd7c-45f0-82d3-2caeced43717"> <td align="left" styleCode="Botrule Rrule">Infection Viral</td> <td align="center" styleCode="Botrule Rrule">29 </td> <td align="center" styleCode="Botrule Rrule">(9.0)</td> <td align="center" styleCode="Botrule Rrule">29 </td> <td align="center" styleCode="Botrule Lrule">(8.9)</td> </tr> <tr ID="id_6445b217-1028-4852-8513-2f5ece6cfebd"> <td align="left" styleCode="Botrule Rrule">Influenza-like Symptoms</td> <td align="center" styleCode="Botrule Rrule">21 </td> <td align="center" styleCode="Botrule Rrule">(6.5)</td> <td align="center" styleCode="Botrule Rrule">19 </td> <td align="center" styleCode="Botrule Lrule">(5.8)</td> </tr> <tr ID="id_ee68f2e9-b0e3-48ce-866e-db7c48e4a8aa"> <td align="left" styleCode="Botrule Rrule"> <content styleCode="bold"> <content styleCode="underline">Digestive System</content> </content> </td> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Lrule"/> </tr> <tr ID="id_a7762b5c-4c4e-4122-998a-71cb75840491"> <td align="left" styleCode="Botrule Rrule">Abdominal Pain</td> <td align="center" styleCode="Botrule Rrule">20 </td> <td align="center" styleCode="Botrule Rrule">(6.2)</td> <td align="center" styleCode="Botrule Rrule">39 </td> <td align="center" styleCode="Botrule Lrule">(12.0)</td> </tr> <tr ID="id_7b53020e-fd2d-4fb4-b585-cc3b1d120651"> <td align="left" styleCode="Botrule Rrule">Constipation</td> <td align="center" styleCode="Botrule Rrule">85 </td> <td align="center" styleCode="Botrule Rrule">(26.4)</td> <td align="center" styleCode="Botrule Rrule">72 </td> <td align="center" styleCode="Botrule Lrule">(22.2)</td> </tr> <tr ID="id_6b60cfff-8b6f-4602-bfcd-775ac545708a"> <td align="left" styleCode="Botrule Rrule">Diarrhea</td> <td align="center" styleCode="Botrule Rrule">81 </td> <td align="center" styleCode="Botrule Rrule">(25.2)</td> <td align="center" styleCode="Botrule Rrule">68 </td> <td align="center" styleCode="Botrule Lrule">(20.9)</td> </tr> <tr ID="id_b00dbb16-8222-43a2-a93c-8b2ed1ee8553"> <td align="left" styleCode="Botrule Rrule">Flatulence</td> <td align="center" styleCode="Botrule Rrule">15 </td> <td align="center" styleCode="Botrule Rrule">(4.7)</td> <td align="center" styleCode="Botrule Rrule">24 </td> <td align="center" styleCode="Botrule Lrule">(7.4)</td> </tr> <tr ID="id_bc74ff06-dc78-4e26-b42f-7bbc3761c5ad"> <td align="left" styleCode="Botrule Rrule">Nausea</td> <td align="center" styleCode="Botrule Rrule">56 </td> <td align="center" styleCode="Botrule Rrule">(17.4)</td> <td align="center" styleCode="Botrule Rrule">43 </td> <td align="center" styleCode="Botrule Lrule">(13.2)</td> </tr> <tr ID="id_45559a6c-8fa4-4cb6-99e2-7b014c17edb2"> <td align="left" styleCode="Botrule Rrule">Vomiting </td> <td align="center" styleCode="Botrule Rrule">44 </td> <td align="center" styleCode="Botrule Rrule">(13.7)</td> <td align="center" styleCode="Botrule Rrule">44 </td> <td align="center" styleCode="Botrule Lrule">(13.5)</td> </tr> <tr ID="id_598362f6-6da1-4af3-927d-8306244fcc55"> <td align="left" styleCode="Botrule Rrule"> <content styleCode="bold"> <content styleCode="underline">Musculoskeletal System</content> </content> </td> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Rrule"/> <td align="left" styleCode="Botrule Lrule"/> </tr> <tr ID="id_72f16331-5e49-49f3-8e25-febb20e50ea5"> <td align="left" styleCode="Botrule Rrule">Back Pain</td> <td align="center" styleCode="Botrule Rrule">38 </td> <td align="center" styleCode="Botrule Rrule">(11.8)</td> <td align="center" styleCode="Botrule Rrule">21 </td> <td align="center" styleCode="Botrule Lrule">(6.5)</td> </tr> <tr ID="id_ca5afc71-c6cc-4058-a146-75ea3e96e17e"> <td align="left" styleCode="Botrule Rrule">Musculoskeletal Pain</td> <td align="center" styleCode="Botrule Rrule">19 </td> <td align="center" styleCode="Botrule Rrule">(5.9)</td> <td align="center" styleCode="Botrule Rrule">15 </td> <td align="center" styleCode="Botrule Lrule">(4.6)</td> </tr> <tr ID="id_62237b14-8d15-4011-aeb9-f90c246b753b"> <td align="left" styleCode="Botrule Rrule"> <content styleCode="bold"> <content styleCode="underline">Nervous System</content> </content> </td> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Lrule"/> </tr> <tr ID="id_374ce23a-a8b7-40fb-8957-724e1b1bed52"> <td align="left" styleCode="Botrule Rrule">Dizziness </td> <td align="center" styleCode="Botrule Rrule">53 </td> <td align="center" styleCode="Botrule Rrule">(16.5)</td> <td align="center" styleCode="Botrule Rrule">42 </td> <td align="center" styleCode="Botrule Lrule">(12.9)</td> </tr> <tr ID="id_eb1b990d-ae44-47da-a46e-d467d7bdbcdf"> <td align="left" styleCode="Botrule Rrule">Headache</td> <td align="center" styleCode="Botrule Rrule">80 </td> <td align="center" styleCode="Botrule Rrule">(24.8)</td> <td align="center" styleCode="Botrule Rrule">78 </td> <td align="center" styleCode="Botrule Lrule">(24.0)</td> </tr> <tr ID="id_9868bfd2-d5a8-406b-b56b-26b8713baa53"> <td align="left" styleCode="Botrule Rrule"> <content styleCode="bold"> <content styleCode="underline">Respiratory System</content> </content> </td> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Lrule"/> </tr> <tr ID="id_4c429b16-3390-4299-9107-c1aa732ceb15"> <td align="left" styleCode="Botrule Rrule">Pharyngitis</td> <td align="center" styleCode="Botrule Rrule">10 </td> <td align="center" styleCode="Botrule Rrule">(3.1)</td> <td align="center" styleCode="Botrule Rrule">19 </td> <td align="center" styleCode="Botrule Lrule">(5.8)</td> </tr> <tr ID="id_28cf3313-92b7-4e88-871c-c39484c9d4be"> <td align="left" styleCode="Botrule Rrule">Sinusitis</td> <td align="center" styleCode="Botrule Rrule">17</td> <td align="center" styleCode="Botrule Rrule">(5.3)</td> <td align="center" styleCode="Botrule Rrule">18</td> <td align="center" styleCode="Botrule Lrule">(5.5)</td> </tr> <tr ID="id_dd374a3a-ccbc-4623-8223-7850cfe10259"> <td align="left" styleCode="Botrule Rrule">Upper Respiratory Tract Infection</td> <td align="center" styleCode="Botrule Rrule">40 </td> <td align="center" styleCode="Botrule Rrule">(12.4)</td> <td align="center" styleCode="Botrule Rrule">35 </td> <td align="center" styleCode="Botrule Lrule">(10.8)</td> </tr> <tr ID="id_edba8d8c-dc2f-45ff-bc7f-86cfbfd8061d"> <td align="left" styleCode="Botrule Rrule"> <content styleCode="bold"> <content styleCode="underline">Skin and Appendages</content> </content> </td> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Lrule"/> </tr> <tr ID="id_f26036b0-1a9f-489e-bf68-5d4cc3a777d9"> <td align="left" styleCode="Botrule Rrule">Alopecia</td> <td align="center" styleCode="Botrule Rrule">17 </td> <td align="center" styleCode="Botrule Rrule">(5.3)</td> <td align="center" styleCode="Botrule Rrule">8 </td> <td align="center" styleCode="Botrule Lrule">(2.5)</td> </tr> <tr ID="id_65671bad-18f5-4ac1-a383-ab060950a81e"> <td align="left" styleCode="Botrule Rrule"> <content styleCode="bold"> <content styleCode="underline">Urogenital System</content> </content> </td> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Rrule"/> <td align="center" styleCode="Botrule Lrule"/> </tr> <tr ID="id_811bf3eb-618c-441d-a542-b4a720fd6e83"> <td align="left" styleCode="Rrule">Dysmenorrhea</td> <td align="center" styleCode="Rrule">18 </td> <td align="center" styleCode="Rrule">(5.6)</td> <td align="center" styleCode="Rrule">19 </td> <td align="center" styleCode="Botrule">(5.8)</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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