Does URSODIOL Cause Exposure during pregnancy? 162 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 162 reports of Exposure during pregnancy have been filed in association with URSODIOL (Ursodiol). This represents 4.5% of all adverse event reports for URSODIOL.
162
Reports of Exposure during pregnancy with URSODIOL
4.5%
of all URSODIOL reports
2
Deaths
72
Hospitalizations
How Dangerous Is Exposure during pregnancy From URSODIOL?
Of the 162 reports, 2 (1.2%) resulted in death, 72 (44.4%) required hospitalization, and 13 (8.0%) were considered life-threatening.
Is Exposure during pregnancy Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for URSODIOL. However, 162 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)
Nausea (149)
Product use in unapproved indication (135)
Death (124)
Diarrhoea (115)
What Other Drugs Cause Exposure during pregnancy?
ADALIMUMAB (4,556)
ACETAMINOPHEN (4,395)
INFLIXIMAB (3,636)
PREDNISONE (2,906)
HYDROXYCHLOROQUINE (2,610)
RITUXIMAB (2,468)
CETIRIZINE (2,435)
TOCILIZUMAB (2,342)
FOLIC ACID (2,318)
LEFLUNOMIDE (2,264)
Which URSODIOL Alternatives Have Lower Exposure during pregnancy Risk?
URSODIOL vs USTEKINUMAB
URSODIOL vs USTEKINUMAB-STBA
URSODIOL vs VADADUSTAT
URSODIOL vs VALACYCLOVIR
URSODIOL vs VALBENAZINE