Does DENOSUMAB Cause Colitis? 118 Reports in FDA Database

Q: Does DENOSUMAB cause Colitis?

118 reports of Colitis have been filed with the FDA for DENOSUMAB, representing 0.1% of all DENOSUMAB adverse event reports.

Q: How dangerous is Colitis from DENOSUMAB?

Of 118 reports, 13 (11.0%) resulted in death and 63 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 118 reports of Colitis have been filed in association with DENOSUMAB (Bilprevda). This represents 0.1% of all adverse event reports for DENOSUMAB.

118

Reports of Colitis with DENOSUMAB

0.1%

of all DENOSUMAB reports

Deaths

Hospitalizations

How Dangerous Is Colitis From DENOSUMAB?

Of the 118 reports, 13 (11.0%) resulted in death, 63 (53.4%) required hospitalization, and 4 (3.4%) 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 DENOSUMAB. However, 118 reports have been filed with the FAERS database.

What Other Side Effects Does DENOSUMAB Cause?

Off label use (34,612) Death (16,545) Osteonecrosis of jaw (8,438) Arthralgia (5,890) Pain in extremity (4,541) Back pain (4,465) Pain (4,102) Product storage error (3,621) Fall (3,322) Fatigue (3,009)

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 DENOSUMAB Alternatives Have Lower Colitis Risk?

DENOSUMAB vs DEOXYCHOLIC ACID DENOSUMAB vs DEPAKINE CHRONO DENOSUMAB vs DEPAKOTE DENOSUMAB vs DEPO-PROVERA DENOSUMAB vs DERMATOPHAGOIDES FARINAE

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