URSODIOL for Prophylaxis: Side Effects & Safety Data
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There are 199 adverse event reports in the FDA FAERS database where URSODIOL was used for Prophylaxis.
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)
Cholestasis of pregnancy (172)
Cholestasis (150)
Cholelithiasis (99)
Cholangitis sclerosing (82)
Cholangitis (69)
Pruritus (64)
Foetal exposure during pregnancy (61)
Liver disorder (58)
Other Drugs Used for Prophylaxis
PEGFILGRASTIM (7,424)
HUMAN C1-ESTERASE INHIBITOR (5,950)
DENOSUMAB (4,541)
SULFAMETHOXAZOLE\TRIMETHOPRIM (3,197)
ASPIRIN (2,083)
VALACYCLOVIR (1,574)
PANTOPRAZOLE (1,502)
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (1,444)
CLOPIDOGREL BISULFATE (1,296)
ENOXAPARIN (1,278)