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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does URSODIOL Cause Hepatic failure? 63 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 63 reports of Hepatic failure have been filed in association with URSODIOL (Ursodiol). This represents 1.7% of all adverse event reports for URSODIOL.

63
Reports of Hepatic failure with URSODIOL
1.7%
of all URSODIOL reports
42
Deaths
17
Hospitalizations

How Dangerous Is Hepatic failure From URSODIOL?

Of the 63 reports, 42 (66.7%) resulted in death, 17 (27.0%) required hospitalization, and 6 (9.5%) were considered life-threatening.

Is Hepatic failure Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for URSODIOL. However, 63 reports have been filed with the FAERS database.

What Other Side Effects Does URSODIOL Cause?

Off label use (444) Drug ineffective (383) Foetal exposure during pregnancy (262) Maternal exposure during pregnancy (210) Pruritus (197) Premature baby (176) Exposure during pregnancy (162) Nausea (149) Product use in unapproved indication (135) Death (124)

What Other Drugs Cause Hepatic failure?

ACETAMINOPHEN (1,392) RIBAVIRIN (888) CYCLOPHOSPHAMIDE (629) METHOTREXATE (598) BEVACIZUMAB (558) SOFOSBUVIR (525) RITUXIMAB (513) VINCRISTINE (468) DOXORUBICIN (462) PREDNISOLONE (425)

Which URSODIOL Alternatives Have Lower Hepatic failure Risk?

URSODIOL vs USTEKINUMAB URSODIOL vs USTEKINUMAB-STBA URSODIOL vs VADADUSTAT URSODIOL vs VALACYCLOVIR URSODIOL vs VALBENAZINE

Related Pages

URSODIOL Full Profile All Hepatic failure Reports All Drugs Causing Hepatic failure URSODIOL Demographics