SOTORASIB for Off label use: Side Effects & Safety Data
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There are 33 adverse event reports in the FDA FAERS database where SOTORASIB was used for Off label use.
Most Reported Side Effects for SOTORASIB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Non-small cell lung cancer | 483 | 16.5% | 131 | 55 |
| Death | 319 | 10.9% | 311 | 19 |
| Disease progression | 314 | 10.7% | 83 | 9 |
| Diarrhoea | 284 | 9.7% | 39 | 62 |
| Off label use | 193 | 6.6% | 41 | 22 |
| Nausea | 98 | 3.4% | 16 | 27 |
| Non-small cell lung cancer metastatic | 93 | 3.2% | 33 | 16 |
| Hepatotoxicity | 91 | 3.1% | 16 | 16 |
| Fatigue | 87 | 3.0% | 5 | 14 |
| Hepatic function abnormal | 80 | 2.7% | 12 | 27 |
| Aspartate aminotransferase increased | 71 | 2.4% | 6 | 19 |
| Alanine aminotransferase increased | 70 | 2.4% | 5 | 17 |
| Lung neoplasm malignant | 64 | 2.2% | 17 | 8 |
| Drug ineffective | 62 | 2.1% | 8 | 5 |
| Decreased appetite | 56 | 1.9% | 11 | 16 |
Other Indications for SOTORASIB
Non-small cell lung cancer (897)
Product used for unknown indication (850)
K-ras gene mutation (752)
Lung neoplasm malignant (353)
Non-small cell lung cancer stage iv (159)
Lung adenocarcinoma (104)
Non-small cell lung cancer metastatic (70)
Lung adenocarcinoma stage iv (39)
Colorectal cancer metastatic (35)
Non-small cell lung cancer recurrent (28)
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)