Does GOLIMUMAB Cause Hepatitis? 544 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 544 reports of Hepatitis have been filed in association with GOLIMUMAB (SIMPONI ARIA). This represents 0.8% of all adverse event reports for GOLIMUMAB.
544
Reports of Hepatitis with GOLIMUMAB
0.8%
of all GOLIMUMAB reports
300
Deaths
399
Hospitalizations
How Dangerous Is Hepatitis From GOLIMUMAB?
Of the 544 reports, 300 (55.1%) resulted in death, 399 (73.3%) required hospitalization, and 299 (55.0%) were considered life-threatening.
Is Hepatitis Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for GOLIMUMAB. However, 544 reports have been filed with the FAERS database.
What Other Side Effects Does GOLIMUMAB Cause?
Drug ineffective (17,959)
Rheumatoid arthritis (12,272)
Pain (11,443)
Fatigue (9,626)
Off label use (8,764)
Alopecia (8,394)
Rash (8,331)
Joint swelling (8,264)
Arthralgia (7,968)
Abdominal discomfort (7,902)
What Other Drugs Cause Hepatitis?
METHOTREXATE (1,835)
ACETAMINOPHEN (1,450)
TOCILIZUMAB (1,184)
HYDROXYCHLOROQUINE (1,133)
ADALIMUMAB (1,096)
RITUXIMAB (1,017)
ETANERCEPT (1,013)
LEFLUNOMIDE (997)
PEMBROLIZUMAB (935)
NIVOLUMAB (930)