Drug information for URSO FORTE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 500MG Prescription AB (Reference Drug) URSODIOL Ursodeoxycholic Acid APTALIS PHARMA US 20675
2009-12-02 Label
2008-03-13 Letter
2008-03-13 Label
2004-09-29 Letter
2004-07-28 Letter
2004-07-28 Label
2001-03-08 Letter
2001-03-08 Letter
1997-12-10 Review

Drug Adverse Effects information for URSO FORTE

Role code Indications Reaction # Reports
C ACNE ABDOMINAL DISTENSION 6
C ACNE ABDOMINAL PAIN UPPER 6
C ACNE ANHEDONIA 6
C ACNE ANXIETY 6
C ACNE CHOLECYSTITIS CHRONIC 2
C ACNE DIARRHOEA 6
C ACNE EMOTIONAL DISTRESS 6
C ACNE GALLBLADDER DISORDER 6
C ACNE GASTROENTERITIS EOSINOPHILIC 6
C ACNE GENERAL PHYSICAL HEALTH DETERIORATION 6
C ACNE INJURY 6
C ACNE MUSCULOSKELETAL PAIN 2
C ACNE NAUSEA 6
C ACNE PAIN 6
C ACNE REFLUX GASTRITIS 6
C CONTRACEPTION ABDOMINAL DISTENSION 2
C CONTRACEPTION ABDOMINAL PAIN UPPER 2
C CONTRACEPTION ANHEDONIA 2
C CONTRACEPTION ANXIETY 2
C CONTRACEPTION BILIARY DYSKINESIA 2
C CONTRACEPTION CHOLECYSTITIS CHRONIC 2
C CONTRACEPTION DIARRHOEA 2
C CONTRACEPTION EMOTIONAL DISTRESS 2
C CONTRACEPTION GALLBLADDER DISORDER 4
C CONTRACEPTION GASTROENTERITIS EOSINOPHILIC 2
C CONTRACEPTION GENERAL PHYSICAL HEALTH DETERIORATION 2
C CONTRACEPTION INJURY 4
C CONTRACEPTION MUSCULOSKELETAL PAIN 2
C CONTRACEPTION NAUSEA 2
C CONTRACEPTION PAIN 4
C CONTRACEPTION REFLUX GASTRITIS 2
C GASTROINTESTINAL DISORDER ABDOMINAL DISTENSION 6
C GASTROINTESTINAL DISORDER ABDOMINAL PAIN UPPER 6
C GASTROINTESTINAL DISORDER ANHEDONIA 6
C GASTROINTESTINAL DISORDER ANXIETY 6
C GASTROINTESTINAL DISORDER CHOLECYSTITIS CHRONIC 2
C GASTROINTESTINAL DISORDER DIARRHOEA 6
C GASTROINTESTINAL DISORDER EMOTIONAL DISTRESS 6
C GASTROINTESTINAL DISORDER GALLBLADDER DISORDER 6
C GASTROINTESTINAL DISORDER GASTROENTERITIS EOSINOPHILIC 6
C GASTROINTESTINAL DISORDER GENERAL PHYSICAL HEALTH DETERIORATION 6
C GASTROINTESTINAL DISORDER INJURY 6
C GASTROINTESTINAL DISORDER MUSCULOSKELETAL PAIN 2
C GASTROINTESTINAL DISORDER NAUSEA 6
C GASTROINTESTINAL DISORDER PAIN 6
C GASTROINTESTINAL DISORDER REFLUX GASTRITIS 6
C HEPATITIS C ANAEMIA 3
C HEPATITIS C DIARRHOEA 3
C HEPATITIS C FATIGUE 3
C HEPATITIS C LOSS OF CONSCIOUSNESS 3
C IDIOPATHIC THROMBOCYTOPENIC PURPURA ARTHRALGIA 1
C IDIOPATHIC THROMBOCYTOPENIC PURPURA COUGH 1
C IDIOPATHIC THROMBOCYTOPENIC PURPURA MALAISE 1
C IDIOPATHIC THROMBOCYTOPENIC PURPURA PLATELET COUNT DECREASED 1
C IDIOPATHIC THROMBOCYTOPENIC PURPURA RHINORRHOEA 1
C MUSCLE SPASMS ABDOMINAL DISTENSION 6
C MUSCLE SPASMS ABDOMINAL PAIN UPPER 6
C MUSCLE SPASMS ANHEDONIA 6
C MUSCLE SPASMS ANXIETY 6
C MUSCLE SPASMS CHOLECYSTITIS CHRONIC 2
C MUSCLE SPASMS DIARRHOEA 6
C MUSCLE SPASMS EMOTIONAL DISTRESS 6
C MUSCLE SPASMS GALLBLADDER DISORDER 6
C MUSCLE SPASMS GASTROENTERITIS EOSINOPHILIC 6
C MUSCLE SPASMS GENERAL PHYSICAL HEALTH DETERIORATION 6
C MUSCLE SPASMS INJURY 6
C MUSCLE SPASMS MUSCULOSKELETAL PAIN 2
C MUSCLE SPASMS NAUSEA 6
C MUSCLE SPASMS PAIN 6
C MUSCLE SPASMS REFLUX GASTRITIS 6
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE ERYTHEMA 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE PAIN 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE PRURITUS 2
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE REACTION 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE SWELLING 2
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