Does URSODIOL Cause Dyspepsia? 31 Reports in FDA Database

Q: Does URSODIOL cause Dyspepsia?

31 reports of Dyspepsia have been filed with the FDA for URSODIOL, representing 0.9% of all URSODIOL adverse event reports.

Q: How dangerous is Dyspepsia from URSODIOL?

Of 31 reports, 3 (9.7%) resulted in death and 5 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 31 reports of Dyspepsia have been filed in association with URSODIOL (Ursodiol). This represents 0.9% of all adverse event reports for URSODIOL.

Reports of Dyspepsia with URSODIOL

0.9%

of all URSODIOL reports

Deaths

Hospitalizations

How Dangerous Is Dyspepsia From URSODIOL?

Of the 31 reports, 3 (9.7%) resulted in death, 5 (16.1%) required hospitalization.

Is Dyspepsia Listed in the Official Label?

Yes, Dyspepsia 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 Dyspepsia?

ADALIMUMAB (3,586) METHOTREXATE (2,690) RITUXIMAB (2,289) TOFACITINIB (2,264) PREDNISONE (2,224) APREMILAST (2,207) ETANERCEPT (2,100) ESOMEPRAZOLE (2,064) TOCILIZUMAB (2,046) LEFLUNOMIDE (1,981)

Which URSODIOL Alternatives Have Lower Dyspepsia Risk?

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

URSODIOL Full Profile All Dyspepsia Reports All Drugs Causing Dyspepsia URSODIOL Demographics