Does URSODIOL Cause Product use in unapproved indication? 135 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 135 reports of Product use in unapproved indication have been filed in association with URSODIOL (Ursodiol). This represents 3.7% of all adverse event reports for URSODIOL.
135
Reports of Product use in unapproved indication with URSODIOL
3.7%
of all URSODIOL reports
38
Deaths
33
Hospitalizations
How Dangerous Is Product use in unapproved indication From URSODIOL?
Of the 135 reports, 38 (28.1%) resulted in death, 33 (24.4%) required hospitalization, and 16 (11.9%) were considered life-threatening.
Is Product use in unapproved indication Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for URSODIOL. However, 135 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)
Death (124)
Diarrhoea (115)
What Other Drugs Cause Product use in unapproved indication?
DUPILUMAB (33,452)
DICLOFENAC (12,197)
METHOTREXATE (8,930)
PREDNISONE (7,625)
RITUXIMAB (7,519)
MYCOPHENOLATE MOFETIL (5,910)
ACETAMINOPHEN (5,819)
CYCLOPHOSPHAMIDE (5,750)
RISPERIDONE (5,551)
TACROLIMUS (5,057)
Which URSODIOL Alternatives Have Lower Product use in unapproved indication Risk?
URSODIOL vs USTEKINUMAB
URSODIOL vs USTEKINUMAB-STBA
URSODIOL vs VADADUSTAT
URSODIOL vs VALACYCLOVIR
URSODIOL vs VALBENAZINE