Ursosiol

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

Top reporter: Kvk-Tech, Inc.

Bile Acid [EPC]Corticosteroid [EPC]Proton Pump Inhibitor [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Osmotic Laxative [EPC]
18,719
Total Reports
10,986
Serious Reports
2,350
Death Reports
30
Reported Reactions
Death Report Ratio: High (12.55%)

Patient Demographics

Male
6,894
Female
9,448

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Ursosiol.

# Reaction Reports % of Total
1 OFF LABEL USE 1,676
9.4%
2 PRURITUS 1,232
6.9%
3 DIARRHOEA 1,026
5.7%
4 FATIGUE 1,025
5.7%
5 NAUSEA 940
5.3%
6 DRUG INEFFECTIVE 893
5.0%
7 PYREXIA 797
4.5%
8 DEATH 675
3.8%
9 PNEUMONIA 671
3.8%
10 VOMITING 616
3.4%
11 HEADACHE 574
3.2%
12 DYSPNOEA 535
3.0%
13 ABDOMINAL PAIN 503
2.8%
14 ASTHENIA 465
2.6%
15 DIZZINESS 450
2.5%
16 RASH 440
2.5%
17 PAIN 420
2.3%
18 DECREASED APPETITE 419
2.3%
19 ARTHRALGIA 411
2.3%
20 ANAEMIA 406
2.3%
21 WEIGHT DECREASED 401
2.2%
22 ACUTE KIDNEY INJURY 392
2.2%
23 COUGH 390
2.2%
24 FEBRILE NEUTROPENIA 375
2.1%
25 MALAISE 374
2.1%
26 CONDITION AGGRAVATED 371
2.1%
27 CONSTIPATION 365
2.0%
28 SEPSIS 359
2.0%
29 PRODUCT DOSE OMISSION ISSUE 354
2.0%
30 ABDOMINAL PAIN UPPER 332
1.9%

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.