Does URSODIOL Cause Hepatitis? 21 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 21 reports of Hepatitis have been filed in association with URSODIOL (Ursodiol). This represents 0.6% of all adverse event reports for URSODIOL.
21
Reports of Hepatitis with URSODIOL
0.6%
of all URSODIOL reports
3
Deaths
9
Hospitalizations
How Dangerous Is Hepatitis From URSODIOL?
Of the 21 reports, 3 (14.3%) resulted in death, 9 (42.9%) required hospitalization, and 1 (4.8%) were considered life-threatening.
Is Hepatitis Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for URSODIOL. However, 21 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 Hepatitis?
METHOTREXATE (1,835)
ACETAMINOPHEN (1,450)
TOCILIZUMAB (1,184)
HYDROXYCHLOROQUINE (1,133)
ADALIMUMAB (1,096)
RITUXIMAB (1,017)
ETANERCEPT (1,013)
LEFLUNOMIDE (997)
PEMBROLIZUMAB (935)
NIVOLUMAB (930)
Which URSODIOL Alternatives Have Lower Hepatitis Risk?
URSODIOL vs USTEKINUMAB
URSODIOL vs USTEKINUMAB-STBA
URSODIOL vs VADADUSTAT
URSODIOL vs VALACYCLOVIR
URSODIOL vs VALBENAZINE