IMATINIB for Off label use: Side Effects & Safety Data
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There are 29 adverse event reports in the FDA FAERS database where IMATINIB was used for Off label use.
Most Reported Side Effects for IMATINIB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 9,708 | 22.5% | 9,693 | 350 |
| Drug ineffective | 2,628 | 6.1% | 359 | 336 |
| Nausea | 2,379 | 5.5% | 271 | 468 |
| Diarrhoea | 2,203 | 5.1% | 351 | 465 |
| Fatigue | 1,810 | 4.2% | 262 | 324 |
| Malignant neoplasm progression | 1,716 | 4.0% | 701 | 227 |
| Vomiting | 1,599 | 3.7% | 319 | 495 |
| Malaise | 1,361 | 3.2% | 337 | 283 |
| Drug intolerance | 1,354 | 3.1% | 112 | 172 |
| Drug resistance | 1,293 | 3.0% | 220 | 142 |
| Rash | 1,272 | 3.0% | 59 | 226 |
| Dyspnoea | 1,205 | 2.8% | 382 | 437 |
| Pyrexia | 1,183 | 2.7% | 425 | 575 |
| Anaemia | 1,029 | 2.4% | 235 | 380 |
| Chronic myeloid leukaemia | 1,005 | 2.3% | 463 | 134 |
Other Indications for IMATINIB
Chronic myeloid leukaemia (18,795)
Product used for unknown indication (9,260)
Gastrointestinal stromal tumour (5,587)
Acute lymphocytic leukaemia (1,884)
Philadelphia positive chronic myeloid leukaemia (284)
Leukaemia (281)
Philadelphia positive acute lymphocytic leukaemia (272)
Neoplasm malignant (261)
Philadelphia chromosome positive (245)
Graft versus host disease (187)
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)