Does BUDESONIDE Cause Large intestine perforation? 13 Reports in FDA Database

Q: Does BUDESONIDE cause Large intestine perforation?

13 reports of Large intestine perforation have been filed with the FDA for BUDESONIDE, representing 0.1% of all BUDESONIDE adverse event reports.

Q: How dangerous is Large intestine perforation from BUDESONIDE?

Of 13 reports, 2 (15.4%) resulted in death and 12 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 13 reports of Large intestine perforation have been filed in association with BUDESONIDE (BREYNA). This represents 0.1% of all adverse event reports for BUDESONIDE.

Reports of Large intestine perforation with BUDESONIDE

0.1%

of all BUDESONIDE reports

Deaths

Hospitalizations

How Dangerous Is Large intestine perforation From BUDESONIDE?

Of the 13 reports, 2 (15.4%) resulted in death, 12 (92.3%) required hospitalization, and 5 (38.5%) were considered life-threatening.

Is Large intestine perforation Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for BUDESONIDE. However, 13 reports have been filed with the FAERS database.

What Other Side Effects Does BUDESONIDE Cause?

Asthma (4,544) Dyspnoea (4,441) Drug ineffective (4,384) Off label use (3,033) Wheezing (2,590) Cough (2,269) Therapeutic product effect incomplete (2,191)