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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does PEMBROLIZUMAB Cause Colitis? 1,638 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 1,638 reports of Colitis have been filed in association with PEMBROLIZUMAB (KEYTRUDA). This represents 2.0% of all adverse event reports for PEMBROLIZUMAB.

1,638
Reports of Colitis with PEMBROLIZUMAB
2.0%
of all PEMBROLIZUMAB reports
238
Deaths
899
Hospitalizations

How Dangerous Is Colitis From PEMBROLIZUMAB?

Of the 1,638 reports, 238 (14.5%) resulted in death, 899 (54.9%) required hospitalization, and 100 (6.1%) were considered life-threatening.

Is Colitis Listed in the Official Label?

Yes, Colitis is listed as a known adverse reaction in the official FDA drug label for PEMBROLIZUMAB.

What Other Side Effects Does PEMBROLIZUMAB Cause?

Malignant neoplasm progression (10,111) Death (4,744) Diarrhoea (4,251) Fatigue (3,833) Off label use (3,416) Product use in unapproved indication (3,191) Pyrexia (3,155) Rash (2,900) Nausea (2,670) Decreased appetite (2,486)

What Other Drugs Cause Colitis?

ADALIMUMAB (3,043) NIVOLUMAB (2,123) IPILIMUMAB (1,988) INFLIXIMAB (1,254) METHOTREXATE (1,166) PREDNISONE (1,100) VEDOLIZUMAB (1,077) CARBOPLATIN (993) MESALAMINE (839) RITUXIMAB (740)

Which PEMBROLIZUMAB Alternatives Have Lower Colitis Risk?

PEMBROLIZUMAB vs PEMETREXED PEMBROLIZUMAB vs PEMIGATINIB PEMBROLIZUMAB vs PENICILLAMINE PEMBROLIZUMAB vs PENICILLIN PEMBROLIZUMAB vs PENICILLIN G

Related Pages

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