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Actigall Side Effects

Generic Name: ursodiol

Please note - some side effects for Actigall may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Actigall - for the Consumer

Actigall

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Actigall:

Constipation; diarrhea; dry skin; gas; headache; indigestion; metallic taste; muscle or joint pain; nausea; skin rash; stomach pain; swelling; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur when using Actigall:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Actigall Side Effects - for the Professional

Actigall

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
 8-10 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
   Actigall  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)
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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have included diarrhea, constipation, dyspepsia, nausea, vomiting and peptic ulcer.

Renal

Renal side effects have included elevated creatinine (1.3%).

Metabolic

Metabolic side effects have included elevated blood glucose (1.3%).

Hematologic

Hematologic side effects have included leukopenia (2.6%) and thrombocytopenia.
.

Dermatologic

Dermatologic side effects have included rash (2.6%).

Musculoskeletal

Musculoskeletal side effects have included back pain (11.8%).

Respiratory

Respiratory side effects have included bronchitis, cough, pharyngitis, rhinitis, and upper respiratory tract infection.

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