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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:

Figure 2
Gallstone Dissolution In Ursodiol and Placebo Patients
GALLSTONE DISSOLUTION

Ursodiol

8 - 10 mg/kg/day

(N=155)

Placebo

(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
Dyspepsia

42
26

(27.1)
(16.8)
34
 18
(21.4)
(7.5)
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 Rrespiratory Tract Infection 24 (15.5) 21 (13.2)
Urogenital System
Urinary Tract Infection 10 (6.5) 7 (4.4)
Figure 3
Gallstone Prevention in Ursodiol and Placebo-Treated Patients
GALLSTONE PREVENTION

Ursodiol

600 mg

(N=322)

Placebo

(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 SUSPECTED URSODIOL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Ursodiol. The information is not vetted and should not be considered as verified clinical evidence.

Possible Ursodiol side effects / adverse reactions in 70 year old female

Reported by a physician from France on 2011-10-24

Patient: 70 year old female weighing 65.0 kg (143.0 pounds)

Reactions: Portal Hypertension, Antimitochondrial Antibody Positive, Biliary Cirrhosis, Cholestasis, Treatment Failure, Disease Progression

Suspect drug(s):
Ursodiol



Possible Ursodiol side effects / adverse reactions in 80 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-24

Patient: 80 year old male

Reactions: Interstitial Lung Disease

Adverse event resulted in: hospitalization

Suspect drug(s):
Ursodiol
    Dosage: 200 mg, qd, oral
    Administration route: Oral
    Indication: Cholelithiasis
    End date: 2011-08-25

Allopurinol
    Dosage: 100 mg, qd, oral
    Administration route: Oral
    Indication: Pain
    Start date: 2011-08-26
    End date: 2011-09-26

Levofloxacin
    Dosage: 500 mg, qd, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-08-25

Other drugs received by patient: Blopress (Candesartan Cilexetil); Forsenid /00571901/(sennoside A+b); Aspirin; Adetphos (Adenosine Triphosphate, Disodium Salt); Diltiazem Hydrochloride; Loxonin /00890702/ (Loxoprofen Sodium); Vibramycin /00055701/ (Doxycycline); Lansoprazole; Mucosta (Rebamipide); Diazepam; Merislon /00141802/ (Betahistine Hydrochloride); Tamsulosin Hydrochloride; Maglax (Magnesium Oxide); Trinosin (Adenosine Triphosphate, Disodium Salt)



Possible Ursodiol side effects / adverse reactions in 80 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-01

Patient: 80 year old male

Reactions: Night Sweats, Dyspnoea, Interstitial Lung Disease, Pyrexia

Adverse event resulted in: hospitalization

Suspect drug(s):
Levofloxacin
    Dosage: 500 mg, qd, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-08-25

Ursodiol
    Dosage: 200 mg, qd, oral
    Administration route: Oral
    Indication: Cholelithiasis
    End date: 2011-08-25

Allopurinol
    Dosage: 100 mg, qd, oral
    Administration route: Oral
    Indication: Pain
    Start date: 2011-08-26
    End date: 2011-09-26

Other drugs received by patient: Vibramycin /00055701/ (Doxycycline); Adetphos (Adenosine Triphosphate, Disodium Salt); Loxonin /00890702/ (Loxoprofen Sodium); Lansoprazole; Merislon /00141802/ (Betahistine Hydrochloride); Maglax (Magnesium Oxide); Tamsulosin Hydrochloride; Mucosta (Rebamipide); Forsenid /00571901/ (Sennoside A+b); Trinosin (Adenosine Triphosphate, Disodium Salt); Blopress (Candesartan Cilexetil); Herbesser R (Diltiazem Hydrochloride) Capsule; Aspirin; Diazepam



See index of all Ursodiol side effect reports >>

Drug label data at the top of this Page last updated: 2014-05-21

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