Does ADALIMUMAB Cause Colitis? 3,043 Reports in FDA Database

Q: Does ADALIMUMAB cause Colitis?

3,043 reports of Colitis have been filed with the FDA for ADALIMUMAB, representing 0.6% of all ADALIMUMAB adverse event reports.

Q: How dangerous is Colitis from ADALIMUMAB?

Of 3,043 reports, 35 (1.2%) resulted in death and 1,732 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 3,043 reports of Colitis have been filed in association with ADALIMUMAB (YUSIMRY). This represents 0.6% of all adverse event reports for ADALIMUMAB.

3,043

Reports of Colitis with ADALIMUMAB

0.6%

of all ADALIMUMAB reports

Deaths

1,732

Hospitalizations

How Dangerous Is Colitis From ADALIMUMAB?

Of the 3,043 reports, 35 (1.2%) resulted in death, 1,732 (56.9%) required hospitalization, and 38 (1.2%) 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 ADALIMUMAB.

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 Colitis?

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) RITUXIMAB (740)

Which ADALIMUMAB Alternatives Have Lower Colitis 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 Colitis Reports All Drugs Causing Colitis ADALIMUMAB Demographics