URSODIOL for Hypertriglyceridaemia: Side Effects & Safety Data
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There are 6 adverse event reports in the FDA FAERS database where URSODIOL was used for Hypertriglyceridaemia.
Most Reported Side Effects for URSODIOL
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 444 | 12.3% | 75 | 136 |
| Drug ineffective | 383 | 10.6% | 89 | 142 |
| Foetal exposure during pregnancy | 262 | 7.2% | 19 | 59 |
| Maternal exposure during pregnancy | 210 | 5.8% | 2 | 63 |
| Pruritus | 197 | 5.4% | 8 | 47 |
| Premature baby | 176 | 4.9% | 12 | 58 |
| Exposure during pregnancy | 162 | 4.5% | 2 | 72 |
| Nausea | 149 | 4.1% | 13 | 67 |
| Product use in unapproved indication | 135 | 3.7% | 38 | 33 |
| Death | 124 | 3.4% | 124 | 19 |
| Diarrhoea | 115 | 3.2% | 9 | 38 |
| Condition aggravated | 97 | 2.7% | 14 | 60 |
| Pneumonia | 96 | 2.7% | 15 | 44 |
| Drug ineffective for unapproved indication | 92 | 2.5% | 12 | 32 |
| Pyrexia | 91 | 2.5% | 14 | 69 |
Other Indications for URSODIOL
Product used for unknown indication (1,357)
Primary biliary cholangitis (203)
Prophylaxis (199)
Cholestasis of pregnancy (172)
Cholestasis (150)
Cholelithiasis (99)
Cholangitis sclerosing (82)
Cholangitis (69)
Pruritus (64)
Foetal exposure during pregnancy (61)
Other Drugs Used for Hypertriglyceridaemia
FENOFIBRATE (517)
ATORVASTATIN (117)
OMEGA-3-CARBOXYLIC ACIDS (116)
GEMFIBROZIL (112)
ICOSAPENT ETHYL (98)
EVOLOCUMAB (70)
OMEGA-3-ACID ETHYL ESTERS (58)
ROSUVASTATIN (54)
ALIROCUMAB (51)
OMEGA-3 FATTY ACIDS (43)