Ursodiol (Ursodiol) - Side Effects and 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:

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

	Ursodiol		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)