Does APREMILAST Cause Stomatitis? 1,582 Reports in FDA Database

Q: Does APREMILAST cause Stomatitis?

1,582 reports of Stomatitis have been filed with the FDA for APREMILAST, representing 1.2% of all APREMILAST adverse event reports.

Q: How dangerous is Stomatitis from APREMILAST?

Of 1,582 reports, 1,314 (83.1%) resulted in death and 1,232 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 1,582 reports of Stomatitis have been filed in association with APREMILAST (Otezla). This represents 1.2% of all adverse event reports for APREMILAST.

1,582

Reports of Stomatitis with APREMILAST

1.2%

of all APREMILAST reports

1,314

Deaths

1,232

Hospitalizations

How Dangerous Is Stomatitis From APREMILAST?

Of the 1,582 reports, 1,314 (83.1%) resulted in death, 1,232 (77.9%) required hospitalization, and 1,197 (75.7%) were considered life-threatening.

Is Stomatitis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for APREMILAST. However, 1,582 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 Stomatitis?

METHOTREXATE (7,245) TOCILIZUMAB (4,761) ADALIMUMAB (4,500) LEFLUNOMIDE (4,492) ABATACEPT (4,481) ETANERCEPT (4,338) RITUXIMAB (4,335) CERTOLIZUMAB PEGOL (3,760) INFLIXIMAB (3,713) PREDNISONE (3,656)

Which APREMILAST Alternatives Have Lower Stomatitis Risk?

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

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