Does URSODIOL Cause Stillbirth? 18 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 18 reports of Stillbirth have been filed in association with URSODIOL (Ursodiol). This represents 0.5% of all adverse event reports for URSODIOL.
18
Reports of Stillbirth with URSODIOL
0.5%
of all URSODIOL reports
4
Deaths
1
Hospitalizations
How Dangerous Is Stillbirth From URSODIOL?
Of the 18 reports, 4 (22.2%) resulted in death, 1 (5.6%) required hospitalization.
Is Stillbirth Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for URSODIOL. However, 18 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 Stillbirth?
HYDROXYPROGESTERONE CAPROATE (542)
LEVETIRACETAM (306)
EMTRICITABINE\TENOFOVIR DISOPROXIL (154)
RITONAVIR (151)
DOLUTEGRAVIR (145)
LAMIVUDINE (144)
EFAVIRENZ (103)
TENOFOVIR DISOPROXIL (95)
ACETAMINOPHEN (91)
NEVIRAPINE (81)
Which URSODIOL Alternatives Have Lower Stillbirth Risk?
URSODIOL vs USTEKINUMAB
URSODIOL vs USTEKINUMAB-STBA
URSODIOL vs VADADUSTAT
URSODIOL vs VALACYCLOVIR
URSODIOL vs VALBENAZINE