ROMIPLOSTIM for Off label use: Side Effects & Safety Data
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There are 48 adverse event reports in the FDA FAERS database where ROMIPLOSTIM was used for Off label use.
Most Reported Side Effects for ROMIPLOSTIM
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 1,027 | 13.7% | 110 | 184 |
| Platelet count decreased | 892 | 11.9% | 42 | 253 |
| Platelet count abnormal | 703 | 9.4% | 9 | 128 |
| Drug ineffective | 513 | 6.8% | 48 | 137 |
| Thrombocytopenia | 369 | 4.9% | 37 | 198 |
| Headache | 359 | 4.8% | 19 | 84 |
| Death | 356 | 4.7% | 356 | 87 |
| Product storage error | 344 | 4.6% | 0 | 3 |
| Fatigue | 251 | 3.3% | 16 | 53 |
| Circumstance or information capable of leading to medication error | 238 | 3.2% | 0 | 1 |
| Thrombocytosis | 234 | 3.1% | 10 | 103 |
| Therapy non-responder | 224 | 3.0% | 24 | 50 |
| Nausea | 192 | 2.6% | 16 | 40 |
| Platelet count increased | 192 | 2.6% | 11 | 65 |
| Haemorrhage | 187 | 2.5% | 36 | 78 |
Other Indications for ROMIPLOSTIM
Immune thrombocytopenic purpura (2,600)
Product used for unknown indication (2,223)
Immune thrombocytopenia (1,358)
Thrombocytopenia (586)
Aplastic anaemia (231)
Platelet count decreased (82)
Thrombocytopenic purpura (53)
Myelodysplastic syndrome (51)
Evans syndrome (39)
Exposure during pregnancy (29)
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)