IVOSIDENIB for Off label use: Side Effects & Safety Data
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There are 27 adverse event reports in the FDA FAERS database where IVOSIDENIB was used for Off label use.
Most Reported Side Effects for IVOSIDENIB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 613 | 36.2% | 31 | 96 |
| Fatigue | 144 | 8.5% | 6 | 17 |
| Diarrhoea | 100 | 5.9% | 4 | 17 |
| Nausea | 100 | 5.9% | 5 | 27 |
| Disease progression | 86 | 5.1% | 19 | 9 |
| Differentiation syndrome | 80 | 4.7% | 22 | 46 |
| Product dose omission issue | 68 | 4.0% | 0 | 16 |
| Drug ineffective | 64 | 3.8% | 12 | 13 |
| Platelet count decreased | 61 | 3.6% | 3 | 27 |
| Electrocardiogram qt prolonged | 58 | 3.4% | 3 | 19 |
| Pneumonia | 51 | 3.0% | 9 | 40 |
| Vomiting | 51 | 3.0% | 4 | 26 |
| Asthenia | 49 | 2.9% | 6 | 17 |
| Febrile neutropenia | 48 | 2.8% | 7 | 43 |
| Product use issue | 43 | 2.5% | 4 | 13 |
Other Indications for IVOSIDENIB
Acute myeloid leukaemia (729)
Cholangiocarcinoma (277)
Product used for unknown indication (194)
Brain neoplasm malignant (140)
Myelodysplastic syndrome (65)
Astrocytoma (20)
Bone cancer (19)
Glioma (16)
Bile duct cancer (15)
Acute leukaemia (13)
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)