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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 Off label use? 444 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 444 reports of Off label use have been filed in association with URSODIOL (Ursodiol). This represents 12.3% of all adverse event reports for URSODIOL.

444
Reports of Off label use with URSODIOL
12.3%
of all URSODIOL reports
75
Deaths
136
Hospitalizations

How Dangerous Is Off label use From URSODIOL?

Of the 444 reports, 75 (16.9%) resulted in death, 136 (30.6%) required hospitalization, and 12 (2.7%) were considered life-threatening.

Is Off label use Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for URSODIOL. However, 444 reports have been filed with the FAERS database.

What Other Side Effects Does URSODIOL Cause?

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) Diarrhoea (115)

What Other Drugs Cause Off label use?

RITUXIMAB (39,751) INFLIXIMAB (34,801) DENOSUMAB (34,612) METHOTREXATE (24,020) VEDOLIZUMAB (21,017) ETANERCEPT (20,178) TOCILIZUMAB (18,256) PREDNISONE (17,867) LENALIDOMIDE (17,017) ADALIMUMAB (16,417)

Which URSODIOL Alternatives Have Lower Off label use Risk?

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

Related Pages

URSODIOL Full Profile All Off label use Reports All Drugs Causing Off label use URSODIOL Demographics