Does URSODIOL Cause Septic shock? 43 Reports in FDA Database

Q: Does URSODIOL cause Septic shock?

43 reports of Septic shock have been filed with the FDA for URSODIOL, representing 1.2% of all URSODIOL adverse event reports.

Q: How dangerous is Septic shock from URSODIOL?

Of 43 reports, 23 (53.5%) resulted in death and 20 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 43 reports of Septic shock have been filed in association with URSODIOL (Ursodiol). This represents 1.2% of all adverse event reports for URSODIOL.

Reports of Septic shock with URSODIOL

1.2%

of all URSODIOL reports

Deaths

Hospitalizations

How Dangerous Is Septic shock From URSODIOL?

Of the 43 reports, 23 (53.5%) resulted in death, 20 (46.5%) required hospitalization, and 7 (16.3%) were considered life-threatening.

Is Septic shock Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for URSODIOL. However, 43 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 Septic shock?

PREDNISONE (2,699) METHOTREXATE (2,330) CYCLOPHOSPHAMIDE (2,187) RITUXIMAB (2,023) DEXAMETHASONE (1,976) TACROLIMUS (1,723) VINCRISTINE (1,548) DOXORUBICIN (1,489) MYCOPHENOLATE MOFETIL (1,475)