FLUOROURACIL for Off label use: Side Effects & Safety Data
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There are 6 adverse event reports in the FDA FAERS database where FLUOROURACIL was used for Off label use.
Most Reported Side Effects for FLUOROURACIL
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Diarrhoea | 5,373 | 10.1% | 623 | 2,692 |
| Neutropenia | 4,400 | 8.3% | 481 | 1,155 |
| Nausea | 3,757 | 7.1% | 363 | 1,741 |
| Vomiting | 2,836 | 5.4% | 362 | 1,661 |
| Off label use | 2,788 | 5.3% | 332 | 955 |
| Neuropathy peripheral | 2,605 | 4.9% | 155 | 368 |
| Thrombocytopenia | 2,426 | 4.6% | 306 | 718 |
| Fatigue | 2,421 | 4.6% | 251 | 953 |
| Disease progression | 2,377 | 4.5% | 596 | 335 |
| Febrile neutropenia | 2,230 | 4.2% | 376 | 1,372 |
| Anaemia | 2,169 | 4.1% | 302 | 917 |
| Pyrexia | 2,162 | 4.1% | 226 | 1,643 |
| Asthenia | 2,043 | 3.9% | 237 | 966 |
| Drug ineffective | 1,833 | 3.5% | 357 | 389 |
| Decreased appetite | 1,714 | 3.2% | 209 | 827 |
Other Indications for FLUOROURACIL
Colorectal cancer metastatic (6,189)
Product used for unknown indication (4,294)
Colon cancer (3,771)
Adenocarcinoma of colon (2,627)
Colorectal cancer (2,440)
Breast cancer (2,383)
Rectal cancer (1,610)
Pancreatic carcinoma (1,556)
Adenocarcinoma gastric (1,276)
Oesophageal carcinoma (1,211)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
ECULIZUMAB (3,550)
CERTOLIZUMAB PEGOL (2,256)
ABOBOTULINUMTOXINA (2,170)
LEVETIRACETAM (2,161)
APREMILAST (1,995)
PROPRANOLOL (1,576)
CETIRIZINE (1,416)
HUMAN IMMUNOGLOBULIN G (1,129)
THALIDOMIDE (1,033)