Does URSODIOL Cause Hypertonia? 11 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 11 reports of Hypertonia have been filed in association with URSODIOL (Ursodiol). This represents 0.3% of all adverse event reports for URSODIOL.
11
Reports of Hypertonia with URSODIOL
0.3%
of all URSODIOL reports
1
Deaths
10
Hospitalizations
How Dangerous Is Hypertonia From URSODIOL?
Of the 11 reports, 1 (9.1%) resulted in death, 10 (90.9%) required hospitalization, and 3 (27.3%) were considered life-threatening.
Is Hypertonia Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for URSODIOL. However, 11 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 Hypertonia?
BACLOFEN (479)
QUETIAPINE (132)
RISPERIDONE (126)
OLANZAPINE (118)
ARIPIPRAZOLE (108)
SERTRALINE (108)
ACETAMINOPHEN (99)
HALOPERIDOL (99)
CLONAZEPAM (84)
VALPROATE (84)
Which URSODIOL Alternatives Have Lower Hypertonia Risk?
URSODIOL vs USTEKINUMAB
URSODIOL vs USTEKINUMAB-STBA
URSODIOL vs VADADUSTAT
URSODIOL vs VALACYCLOVIR
URSODIOL vs VALBENAZINE