Does APREMILAST Cause Colitis? 81 Reports in FDA Database

Q: Does APREMILAST cause Colitis?

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

Q: How dangerous is Colitis from APREMILAST?

Of 81 reports, 2 (2.5%) resulted in death and 19 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 81 reports of Colitis have been filed in association with APREMILAST (Otezla). This represents 0.1% of all adverse event reports for APREMILAST.

Reports of Colitis with APREMILAST

0.1%

of all APREMILAST reports

Deaths

Hospitalizations

How Dangerous Is Colitis From APREMILAST?

Of the 81 reports, 2 (2.5%) resulted in death, 19 (23.5%) required hospitalization, and 2 (2.5%) 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 APREMILAST. However, 81 reports have been filed with the FAERS database.

What Other Side Effects Does APREMILAST Cause?

Diarrhoea (23,752) Nausea (21,352) Psoriasis (19,255) Headache (17,024) Drug ineffective (14,121) Abdominal discomfort (7,653) Psoriatic arthropathy (7,035) Vomiting (5,959) Rash (5,883) Pain (5,676)

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 APREMILAST Alternatives Have Lower Colitis Risk?

APREMILAST vs APREPITANT APREMILAST vs APROTININ APREMILAST vs ARANESP APREMILAST vs ARAVA APREMILAST vs AREDIA

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