Does URSODIOL Cause Malaise? 32 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 32 reports of Malaise have been filed in association with URSODIOL (Ursodiol). This represents 0.9% of all adverse event reports for URSODIOL.
32
Reports of Malaise with URSODIOL
0.9%
of all URSODIOL reports
5
Deaths
14
Hospitalizations
How Dangerous Is Malaise From URSODIOL?
Of the 32 reports, 5 (15.6%) resulted in death, 14 (43.8%) required hospitalization, and 3 (9.4%) were considered life-threatening.
Is Malaise Listed in the Official Label?
Yes, Malaise is listed as a known adverse reaction in the official FDA drug label for URSODIOL.
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 Malaise?
ADALIMUMAB (15,965)
ETANERCEPT (13,600)
METHOTREXATE (9,970)
TOFACITINIB (9,040)
SECUKINUMAB (8,570)
INFLIXIMAB (7,477)
RITUXIMAB (6,587)
PREGABALIN (6,320)
PREDNISONE (6,319)
ABATACEPT (6,251)
Which URSODIOL Alternatives Have Lower Malaise Risk?
URSODIOL vs USTEKINUMAB
URSODIOL vs USTEKINUMAB-STBA
URSODIOL vs VADADUSTAT
URSODIOL vs VALACYCLOVIR
URSODIOL vs VALBENAZINE