Skip to content
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 Product use in unapproved indication? 135 Reports in FDA Database

Boost Your Natural Energy & Metabolism

Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.

Try Mitolyn Now

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

Related Pages

URSODIOL Full Profile All Product use in unapproved indication Reports All Drugs Causing Product use in unapproved indication URSODIOL Demographics