Drug Information for URSODIOL CAPSULES, USP9380Rx only (TEVA Pharmaceuticals USA Inc): ADVERSE REACTIONS

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  • 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
    UrsodiolPlacebo
    8 to 10 mg/kg/day
    (N = 155)(N = 159)
    N(%)N(%)
    Body as a Whole
    Allergy8(5.2)7(4.4)
    Chest Pain5(3.2)10(6.3)
    Fatigue7(4.5)8(5.0)
    Infection Viral30(19.4)41(25.8)
    Digestive System
    Abdominal Pain67(43.2)70(44.0)
    Cholecystitis8(5.2)7(4.4)
    Constipation15(9.7)14(8.8)
    Diarrhea42(27.1)34(21.4)
    Dyspepsia26(16.8)18(11.3)
    Flatulence12(7.7)12(7.5)
    Gastrointestinal Disorder6(3.9)8(5.0)
    Nausea22(14.2)27(17.0)
    Vomiting15(9.7)11(6.9)
    Musculoskeletal System
    Arthralgia12(7.7)24(15.1)
    Arthritis9(5.8)4(2.5)
    Back Pain11(7.1)18(11.3)
    Myalgia9(5.8)9(5.7)
    Nervous System
    Headache28(18.1)34(21.4)
    Insomnia3(1.9)8(5.0)
    Respiratory System
    Bronchitis10(6.5)6(3.8)
    Coughing11(7.1)7(4.4)
    Pharyngitis13(8.4)5(3.1)
    Rhinitis8(5.2)11(6.9)
    Sinusitis17(11.0)18(11.3)
    Upper Respiratory Tract Infection24(15.5)21(13.2)
    Urogenital System
    Urinary Tract Infection10(6.5)7(4.4)
    Gallstone Prevention
    UrsodiolPlacebo
    600 mg
    (N = 322)(N = 325)
    N(%)N(%)
    Body as a Whole
    Fatigue25(7.8)33(10.2)
    Infection Viral29(9.0)29(8.9)
    Influenza-like Symptoms21(6.5)19(5.8)
    Digestive System
    Abdominal Pain20(6.2)39(12.0)
    Constipation85(26.4)72(22.2)
    Diarrhea81(25.2)68(20.9)
    Flatulence15(4.7)24(7.4)
    Nausea56(17.4)43(13.2)
    Vomiting44(13.7)44(13.5)
    Musculoskeletal System
    Back Pain38(11.8)21(6.5)
    Musculoskeletal Pain19(5.9)15(4.6)
    Nervous System
    Dizziness53(16.5)42(12.9)
    Headache80(24.8)78(24.0)
    Respiratory System
    Pharyngitis10(3.1)19(5.8)
    Sinusitis17(5.3)18(5.5)
    Upper Respiratory Tract Infection40(12.4)35(10.8)
    Skin and Appendages
    Alopecia17(5.3)8(2.5)
    Urogenital System
    Dysmenorrhea18(5.6)19(5.8)
  • Drug Information Provided by National Library of Medicine (NLM).
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