Does URSODIOL Cause Drug ineffective for unapproved indication? 92 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 92 reports of Drug ineffective for unapproved indication have been filed in association with URSODIOL (Ursodiol). This represents 2.5% of all adverse event reports for URSODIOL.
92
Reports of Drug ineffective for unapproved indication with URSODIOL
2.5%
of all URSODIOL reports
12
Deaths
32
Hospitalizations
How Dangerous Is Drug ineffective for unapproved indication From URSODIOL?
Of the 92 reports, 12 (13.0%) resulted in death, 32 (34.8%) required hospitalization, and 2 (2.2%) were considered life-threatening.
Is Drug ineffective for unapproved indication Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for URSODIOL. However, 92 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 Drug ineffective for unapproved indication?
GABAPENTIN (5,231)
METHOTREXATE (2,513)
DICLOFENAC (2,154)
RITUXIMAB (1,776)
LIDOCAINE (1,761)
METHYLPREDNISOLONE (1,750)
PREDNISONE (1,598)
MYCOPHENOLATE MOFETIL (1,596)
HUMAN IMMUNOGLOBULIN G (1,527)
DEXAMETHASONE (1,302)
Which URSODIOL Alternatives Have Lower Drug ineffective for unapproved indication Risk?
URSODIOL vs USTEKINUMAB
URSODIOL vs USTEKINUMAB-STBA
URSODIOL vs VADADUSTAT
URSODIOL vs VALACYCLOVIR
URSODIOL vs VALBENAZINE