REMICADE for Crohn's disease: Side Effects & Safety Data
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There are 1,383 adverse event reports in the FDA FAERS database where REMICADE was used for Crohn's disease.
Most Reported Side Effects for REMICADE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Infusion related reaction | 313 | 9.8% | 5 | 79 |
| Crohn's disease | 193 | 6.0% | 2 | 143 |
| Drug ineffective | 157 | 4.9% | 4 | 67 |
| Dyspnoea | 141 | 4.4% | 2 | 38 |
| Exposure during pregnancy | 96 | 3.0% | 0 | 19 |
| Arthralgia | 95 | 3.0% | 1 | 33 |
| Nausea | 85 | 2.7% | 1 | 29 |
| Pain | 84 | 2.6% | 0 | 33 |
| Vomiting | 81 | 2.5% | 0 | 45 |
| Malaise | 80 | 2.5% | 3 | 38 |
| Pyrexia | 77 | 2.4% | 5 | 54 |
| Off label use | 75 | 2.4% | 6 | 29 |
| Diarrhoea | 72 | 2.3% | 1 | 40 |
| Fistula | 71 | 2.2% | 1 | 19 |
| Abdominal pain | 70 | 2.2% | 1 | 42 |
Other Indications for REMICADE
Rheumatoid arthritis (523)
Colitis ulcerative (433)
Product used for unknown indication (240)
Ankylosing spondylitis (199)
Psoriatic arthropathy (168)
Psoriasis (115)
Inflammatory bowel disease (101)
Colitis (29)
Arthritis (21)
Hidradenitis (11)
Other Drugs Used for Crohn's disease
ADALIMUMAB (99,540)
INFLIXIMAB (40,796)
VEDOLIZUMAB (28,718)
USTEKINUMAB (22,537)
RISANKIZUMAB-RZAA (12,561)
INFLIXIMAB-DYYB (10,657)
HUMIRA (10,174)
CERTOLIZUMAB PEGOL (8,758)
UPADACITINIB (4,390)
MESALAMINE (2,930)