Actigall (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

	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)

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ACTIGALL

Possible Actigall side effects / adverse reactions in 3 year old female

Reported by a physician from United States on 2007-06-01

Patient: 3 year old female weighing 14.9 kg (32.8 pounds)

Reactions: Viral Infection, Urticaria

Suspect drug(s):
Actigall
    Dosage: 300mg three times per day
    Administration route: Oral

Augmentin '125'
    Indication: Drug USE FOR Unknown Indication
    End date: 2007-02-01

Other drugs received by patient: Vitamin A; Vitamin D; Vitamin E; Vitamin K

Possible Actigall side effects / adverse reactions in 60 year old male

Reported by a physician from United States on 2007-10-18

Patient: 60 year old male weighing 81.6 kg (179.5 pounds)

Reactions: Cutaneous Vasculitis, Gastritis, Eosinophilia

Adverse event resulted in: hospitalization

Suspect drug(s):
Actigall

Other drugs received by patient: Corticosteroid NOS (Corticosteroid Nos) Aerosol (Inhalation)