PEGFILGRASTIM for Off label use: Side Effects & Safety Data
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There are 248 adverse event reports in the FDA FAERS database where PEGFILGRASTIM was used for Off label use.
Most Reported Side Effects for PEGFILGRASTIM
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Device adhesion issue | 11,326 | 14.0% | 9 | 12 |
| Wrong technique in product usage process | 10,217 | 12.6% | 13 | 80 |
| Unintentional medical device removal | 8,882 | 11.0% | 7 | 23 |
| Device malfunction | 6,818 | 8.4% | 3 | 53 |
| Device use error | 6,001 | 7.4% | 4 | 20 |
| Device issue | 5,071 | 6.3% | 7 | 48 |
| Accidental exposure to product | 4,967 | 6.1% | 1 | 13 |
| Device occlusion | 3,239 | 4.0% | 3 | 13 |
| Off label use | 3,228 | 4.0% | 140 | 299 |
| Bone pain | 2,266 | 2.8% | 48 | 421 |
| Febrile neutropenia | 2,154 | 2.7% | 237 | 1,203 |
| Drug dose omission | 2,089 | 2.6% | 3 | 52 |
| Drug dose omission by device | 2,051 | 2.5% | 3 | 26 |
| Neutropenia | 1,863 | 2.3% | 163 | 659 |
| Intercepted product preparation error | 1,514 | 1.9% | 1 | 1 |
Other Indications for PEGFILGRASTIM
Product used for unknown indication (43,274)
Neutropenia (21,342)
Prophylaxis (7,424)
Breast cancer (813)
B-cell lymphoma (774)
Colony stimulating factor therapy (692)
Breast cancer female (635)
Febrile neutropenia (492)
Colony stimulating factor prophylaxis (436)
Agranulocytosis (272)
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)