Ursodiol

Common brands: Urso 250, Urso Forte, Ursodiol 200 Mg, Ursodiol 400 Mg, Reltone 200 Mg

Top reporter: Allergan, Inc.

Bile Acid [EPC]Corticosteroid [EPC]Proton Pump Inhibitor [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Loop Diuretic [EPC]
21,038
Total Reports
11,597
Serious Reports
2,919
Death Reports
30
Reported Reactions
Death Report Ratio: High (13.87%)

Patient Demographics

Male
8,133
Female
10,461

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Ursodiol.

# Reaction Reports % of Total
1 OFF LABEL USE 1,691
8.6%
2 PRURITUS 1,275
6.5%
3 DIARRHOEA 1,180
6.0%
4 FATIGUE 1,059
5.4%
5 NAUSEA 1,029
5.2%
6 PYREXIA 967
4.9%
7 DRUG INEFFECTIVE 921
4.7%
8 PNEUMONIA 752
3.8%
9 DEATH 699
3.6%
10 VOMITING 669
3.4%
11 HEADACHE 610
3.1%
12 DYSPNOEA 575
2.9%
13 RASH 549
2.8%
14 ABDOMINAL PAIN 535
2.7%
15 DECREASED APPETITE 535
2.7%
16 ANAEMIA 510
2.6%
17 ASTHENIA 490
2.5%
18 DIZZINESS 484
2.5%
19 MALAISE 461
2.3%
20 PAIN 446
2.3%
21 FEBRILE NEUTROPENIA 442
2.2%
22 ARTHRALGIA 436
2.2%
23 PLATELET COUNT DECREASED 434
2.2%
24 SEPSIS 432
2.2%
25 WEIGHT DECREASED 425
2.2%
26 ALANINE AMINOTRANSFERASE INCREASED 418
2.1%
27 COUGH 414
2.1%
28 CONDITION AGGRAVATED 413
2.1%
29 HEPATIC FUNCTION ABNORMAL 406
2.1%
30 CONSTIPATION 396
2.0%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.