Does MESALAMINE Cause Off label use? 2,450 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 2,450 reports of Off label use have been filed in association with MESALAMINE (Mesalamine). This represents 12.6% of all adverse event reports for MESALAMINE.
2,450
Reports of Off label use with MESALAMINE
12.6%
of all MESALAMINE reports
431
Deaths
981
Hospitalizations
How Dangerous Is Off label use From MESALAMINE?
Of the 2,450 reports, 431 (17.6%) resulted in death, 981 (40.0%) required hospitalization, and 356 (14.5%) were considered life-threatening.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for MESALAMINE. However, 2,450 reports have been filed with the FAERS database.
What Other Side Effects Does MESALAMINE Cause?
Drug ineffective (4,753)
Colitis ulcerative (2,427)
Diarrhoea (1,874)
Condition aggravated (1,838)
Pyrexia (1,467)
Haematochezia (1,456)
Fatigue (1,442)
Headache (1,435)
Pain (1,395)
Nausea (1,350)
What Other Drugs Cause Off label use?
RITUXIMAB (39,751)
INFLIXIMAB (34,801)
DENOSUMAB (34,612)
METHOTREXATE (24,020)
VEDOLIZUMAB (21,017)
ETANERCEPT (20,178)
TOCILIZUMAB (18,256)
PREDNISONE (17,867)
LENALIDOMIDE (17,017)
ADALIMUMAB (16,417)
Which MESALAMINE Alternatives Have Lower Off label use Risk?
MESALAMINE vs MESNA
MESALAMINE vs METAMIZOLE
MESALAMINE vs METARAMINOL
MESALAMINE vs METAXALONE
MESALAMINE vs METFORMIN