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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does MESALAMINE Cause Hepatotoxicity? 52 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 52 reports of Hepatotoxicity have been filed in association with MESALAMINE (Mesalamine). This represents 0.3% of all adverse event reports for MESALAMINE.

52
Reports of Hepatotoxicity with MESALAMINE
0.3%
of all MESALAMINE reports
7
Deaths
26
Hospitalizations

How Dangerous Is Hepatotoxicity From MESALAMINE?

Of the 52 reports, 7 (13.5%) resulted in death, 26 (50.0%) required hospitalization, and 9 (17.3%) were considered life-threatening.

Is Hepatotoxicity Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for MESALAMINE. However, 52 reports have been filed with the FAERS database.

What Other Side Effects Does MESALAMINE Cause?

Drug ineffective (4,753) Off label use (2,450) 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)

What Other Drugs Cause Hepatotoxicity?

METHOTREXATE (1,917) ACETAMINOPHEN (1,557) LEFLUNOMIDE (829) HYDROXYCHLOROQUINE (715) PREDNISONE (707) RITUXIMAB (702) ETANERCEPT (699) ADALIMUMAB (674) CYCLOPHOSPHAMIDE (632) SULFASALAZINE (613)

Which MESALAMINE Alternatives Have Lower Hepatotoxicity Risk?

MESALAMINE vs MESNA MESALAMINE vs METAMIZOLE MESALAMINE vs METARAMINOL MESALAMINE vs METAXALONE MESALAMINE vs METFORMIN

Related Pages

MESALAMINE Full Profile All Hepatotoxicity Reports All Drugs Causing Hepatotoxicity MESALAMINE Demographics