Does URSODIOL Cause Congenital anomaly? 9 Reports in FDA Database

Q: Does URSODIOL cause Congenital anomaly?

9 reports of Congenital anomaly have been filed with the FDA for URSODIOL, representing 0.3% of all URSODIOL adverse event reports.

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According to the FDA Adverse Event Reporting System (FAERS), 9 reports of Congenital anomaly have been filed in association with URSODIOL (Ursodiol). This represents 0.3% of all adverse event reports for URSODIOL.

Reports of Congenital anomaly with URSODIOL

0.3%

of all URSODIOL reports

Deaths

Hospitalizations

How Dangerous Is Congenital anomaly From URSODIOL?

Of the 9 reports, 1 (11.1%) required hospitalization.

Is Congenital anomaly Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for URSODIOL. However, 9 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 Congenital anomaly?

OXYCODONE (683) ACETAMINOPHEN\OXYCODONE (460) ACETAMINOPHEN\HYDROCODONE (439) TRAMADOL (348) HYDROMORPHONE (341) LEVETIRACETAM (334) ONDANSETRON (334) ABATACEPT (322) BUPRENORPHINE (296) MORPHINE (293)

Which URSODIOL Alternatives Have Lower Congenital anomaly Risk?

URSODIOL vs USTEKINUMAB URSODIOL vs USTEKINUMAB-STBA URSODIOL vs VADADUSTAT URSODIOL vs VALACYCLOVIR URSODIOL vs VALBENAZINE

URSODIOL Full Profile All Congenital anomaly Reports All Drugs Causing Congenital anomaly URSODIOL Demographics