Does IBRUTINIB Cause Colitis? 175 Reports in FDA Database

Q: Does IBRUTINIB cause Colitis?

175 reports of Colitis have been filed with the FDA for IBRUTINIB, representing 0.2% of all IBRUTINIB adverse event reports.

Q: How dangerous is Colitis from IBRUTINIB?

Of 175 reports, 33 (18.9%) resulted in death and 116 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 175 reports of Colitis have been filed in association with IBRUTINIB (Imbruvica). This represents 0.2% of all adverse event reports for IBRUTINIB.

175

Reports of Colitis with IBRUTINIB

0.2%

of all IBRUTINIB reports

Deaths

116

Hospitalizations

How Dangerous Is Colitis From IBRUTINIB?

Of the 175 reports, 33 (18.9%) resulted in death, 116 (66.3%) required hospitalization, and 3 (1.7%) were considered life-threatening.

Is Colitis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for IBRUTINIB. However, 175 reports have been filed with the FAERS database.

What Other Side Effects Does IBRUTINIB Cause?

Death (8,007) Off label use (5,446) Fatigue (4,479) Diarrhoea (3,903) Atrial fibrillation (3,671) Pneumonia (3,015) Incorrect dose administered (2,752) Contusion (2,712) Fall (2,375) Asthenia (2,200)

What Other Drugs Cause Colitis?

ADALIMUMAB (3,043) NIVOLUMAB (2,123) IPILIMUMAB (1,988) PEMBROLIZUMAB (1,638) INFLIXIMAB (1,254) METHOTREXATE (1,166) PREDNISONE (1,100) VEDOLIZUMAB (1,077) CARBOPLATIN (993) MESALAMINE (839)

Which IBRUTINIB Alternatives Have Lower Colitis Risk?

IBRUTINIB vs IBUPROFEN IBRUTINIB vs IBUPROFEN LYSINE IBRUTINIB vs IBUPROFEN UNKNOWN PRODUCT IBRUTINIB vs IBUPROFEN\IBUPROFEN IBRUTINIB vs IBUPROFEN\PHENYLEPHRINE

IBRUTINIB Full Profile All Colitis Reports All Drugs Causing Colitis IBRUTINIB Demographics