TRASTUZUMAB for Off label use: Side Effects & Safety Data
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There are 33 adverse event reports in the FDA FAERS database where TRASTUZUMAB was used for Off label use.
Most Reported Side Effects for TRASTUZUMAB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Diarrhoea | 4,996 | 10.7% | 484 | 2,202 |
| Off label use | 3,802 | 8.2% | 801 | 1,145 |
| Nausea | 3,499 | 7.5% | 402 | 1,460 |
| Fatigue | 3,417 | 7.3% | 444 | 1,306 |
| Myelosuppression | 2,552 | 5.5% | 10 | 1,110 |
| Disease progression | 2,449 | 5.3% | 689 | 462 |
| Death | 2,378 | 5.1% | 2,376 | 236 |
| Vomiting | 2,244 | 4.8% | 265 | 1,146 |
| Dyspnoea | 2,010 | 4.3% | 233 | 1,046 |
| Pyrexia | 1,886 | 4.1% | 192 | 1,067 |
| Asthenia | 1,835 | 3.9% | 300 | 708 |
| Neuropathy peripheral | 1,733 | 3.7% | 228 | 495 |
| Neutropenia | 1,627 | 3.5% | 240 | 530 |
| Ejection fraction decreased | 1,579 | 3.4% | 157 | 417 |
| Alopecia | 1,464 | 3.2% | 170 | 324 |
Other Indications for TRASTUZUMAB
Breast cancer (15,522)
Breast cancer metastatic (6,303)
Product used for unknown indication (5,641)
Her2 positive breast cancer (5,549)
Her-2 positive breast cancer (3,520)
Invasive ductal breast carcinoma (1,576)
Breast cancer female (1,068)
Gastric cancer (917)
Invasive breast carcinoma (489)
Neoplasm malignant (476)
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)