Does ADALIMUMAB Cause Stomatitis? 4,500 Reports in FDA Database

Q: Does ADALIMUMAB cause Stomatitis?

4,500 reports of Stomatitis have been filed with the FDA for ADALIMUMAB, representing 0.9% of all ADALIMUMAB adverse event reports.

Q: How dangerous is Stomatitis from ADALIMUMAB?

Of 4,500 reports, 1,568 (34.8%) resulted in death and 2,314 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 4,500 reports of Stomatitis have been filed in association with ADALIMUMAB (YUSIMRY). This represents 0.9% of all adverse event reports for ADALIMUMAB.

4,500

Reports of Stomatitis with ADALIMUMAB

0.9%

of all ADALIMUMAB reports

1,568

Deaths

2,314

Hospitalizations

How Dangerous Is Stomatitis From ADALIMUMAB?

Of the 4,500 reports, 1,568 (34.8%) resulted in death, 2,314 (51.4%) required hospitalization, and 1,828 (40.6%) 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 ADALIMUMAB. However, 4,500 reports have been filed with the FAERS database.

What Other Side Effects Does ADALIMUMAB Cause?

Drug ineffective (71,926) Pain (37,514) Arthralgia (35,592) Rheumatoid arthritis (29,817) Fatigue (29,420) Injection site pain (28,679) Headache (19,891) Nausea (19,299) Rash (18,690) Pain in extremity (18,319)

What Other Drugs Cause Stomatitis?

METHOTREXATE (7,245) TOCILIZUMAB (4,761) LEFLUNOMIDE (4,492) ABATACEPT (4,481) ETANERCEPT (4,338) RITUXIMAB (4,335) CERTOLIZUMAB PEGOL (3,760) INFLIXIMAB (3,713) PREDNISONE (3,656) GOLIMUMAB (3,648)

Which ADALIMUMAB Alternatives Have Lower Stomatitis Risk?

ADALIMUMAB vs ADALIMUMAB-AACF ADALIMUMAB vs ADALIMUMAB-AATY ADALIMUMAB vs ADALIMUMAB-ADAZ ADALIMUMAB vs ADALIMUMAB-ADBM ADALIMUMAB vs ADALIMUMAB-AFZB

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