Does ROFLUMILAST Cause Colitis? 6 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 6 reports of Colitis have been filed in association with ROFLUMILAST (ROFLUMILAST). This represents 0.2% of all adverse event reports for ROFLUMILAST.
6
Reports of Colitis with ROFLUMILAST
0.2%
of all ROFLUMILAST reports
1
Deaths
3
Hospitalizations
How Dangerous Is Colitis From ROFLUMILAST?
Of the 6 reports, 1 (16.7%) resulted in death, 3 (50.0%) required hospitalization, and 1 (16.7%) 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 ROFLUMILAST. However, 6 reports have been filed with the FAERS database.
What Other Side Effects Does ROFLUMILAST Cause?
Death (569)
Dyspnoea (433)
Chronic obstructive pulmonary disease (292)
Diarrhoea (265)
Off label use (242)
Weight decreased (224)
Nausea (191)
Pneumonia (176)
Headache (166)
Malaise (164)
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 ROFLUMILAST Alternatives Have Lower Colitis Risk?
ROFLUMILAST vs ROLAPITANT
ROFLUMILAST vs ROMIDEPSIN
ROFLUMILAST vs ROMIPLOSTIM
ROFLUMILAST vs ROMOSOZUMAB
ROFLUMILAST vs ROMOSOZUMAB-AQQG