MESALAMINE for Colitis: Side Effects & Safety Data
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There are 804 adverse event reports in the FDA FAERS database where MESALAMINE was used for Colitis.
Most Reported Side Effects for MESALAMINE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 4,753 | 24.4% | 360 | 1,405 |
| Off label use | 2,450 | 12.6% | 431 | 981 |
| Colitis ulcerative | 2,427 | 12.5% | 236 | 1,138 |
| Diarrhoea | 1,874 | 9.6% | 383 | 765 |
| Condition aggravated | 1,838 | 9.4% | 564 | 740 |
| Pyrexia | 1,467 | 7.5% | 393 | 887 |
| Haematochezia | 1,456 | 7.5% | 6 | 420 |
| Fatigue | 1,442 | 7.4% | 516 | 678 |
| Headache | 1,435 | 7.4% | 519 | 771 |
| Pain | 1,395 | 7.2% | 414 | 698 |
| Nausea | 1,350 | 6.9% | 364 | 687 |
| Weight decreased | 1,336 | 6.9% | 338 | 684 |
| Abdominal pain | 1,316 | 6.8% | 194 | 714 |
| Frequent bowel movements | 1,238 | 6.4% | 175 | 542 |
| Crohn's disease | 1,235 | 6.3% | 366 | 529 |
Other Indications for MESALAMINE
Product used for unknown indication (7,516)
Colitis ulcerative (6,347)
Crohn's disease (2,930)
Inflammatory bowel disease (301)
Proctitis ulcerative (162)
Colitis microscopic (157)
Rheumatoid arthritis (138)
Proctitis (114)
Irritable bowel syndrome (75)
Diarrhoea (63)
Other Drugs Used for Colitis
INFLIXIMAB (1,248)
VEDOLIZUMAB (805)
ADALIMUMAB (697)
TOFACITINIB (232)
USTEKINUMAB (219)
METRONIDAZOLE (214)
PREDNISONE (198)
PREDNISOLONE (188)
AZATHIOPRINE (181)
METHYLPREDNISOLONE (176)