Ursodiol

INDICATIONS AND USAGE Ursodiol capsules are indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol capsules beyond 24 months is not established. Ursodiol capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

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: GALLSTONE DISSOLUTION Ursodiol 8 mg/kg/day to 10 mg/kg/day(N = 155) Placebo(N = 159) N (%) N (%) Body as a Whole Allergy Chest Pain Fatigue Infection Viral 8 5 7 30 (5.2) (3.2) (4.5) (19.4) 7 10 8 41 (4.4) (6.3) (5.0) (25.8) Digestive System Abdominal Pain Cholecystitis Constipation Diarrhea Dyspepsia Flatulence Gastrointestinal Disorder Nausea Vomiting 67 8 15 42 26 12 6 22 15 (43.2) (5.2) (9.7) (27.1) (16.8) (7.7) (3.9) (14.2) (9.7) 70 7 14 34 18 12 8 27 11 (44.0) (4.4) (8.8) (21.4) (11.3) (7.5) (5.0) (17.0) (6.9) Musculoskeletal System Arthralgia Arthritis Back Pain Myalgia 12 9 11 9 (7.7) (5.8) (7.1) (5.8) 24 4 18 9 (15.1) (2.5) (11.3) (5.7) Nervous System Headache Insomnia 28 3 (18.1) (1.9) 34 8 (21.4) (5.0) Respiratory System Bronchitis Coughing Pharyngitis Rhinitis Sinusitis Upper Respiratory Tract Infection 10 11 13 8 17 24 (6.5) (7.1) (8.4) (5.2) (11.0) (15.5) 6 7 5 11 18 21 (3.8) (4.4) (3.1) (6.9) (11.3) (13.2) Urogenital System Urinary Tract Infection 10 (6.5) 7 (4.4) GALLSTONE PREVENTION Ursodiol 600 mg (N = 322) Placebo (N = 325) N (%) N (%) Body as a Whole Fatigue Infection Viral Influenza-like Symptoms 25 29 21 (7.8) (9.0) (6.5) 33 29 19 (10.2) (8.9) (5.8) Digestive System Abdominal Pain Constipation Diarrhea Flatulence Nausea Vomiting 20 85 81 15 56 44 (6.2) (26.4) (25.2) (4.7) (17.4) (13.7) 39 72 68 24 43 44 (12.0) (22.2) (20.9) (7.4) (13.2) (13.5) Musculoskeletal System Back Pain Musculoskeletal Pain 38 19 (11.8) (5.9) 21 15 (6.5) (4.6) Nervous System Dizziness Headache 53 80 (16.5) (24.8) 42 78 (12.9) (24.0) Respiratory System Pharyngitis Sinusitis Upper Respiratory Tract Infection 10 17 40 (3.1) (5.3) (12.4) 19 18 35 (5.8) (5.5) (10.8) Skin and Appendages Alopecia 17 (5.3) 8 (2.5) Urogenital System Dysmenorrhea 18 (5.6) 19 (5.8) Post-marketing Experience The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post-approval use of ursodiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disorders : enteroliths (bezoars) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.