DARATUMUMAB for Immune tolerance induction: Side Effects & Safety Data
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There are 6 adverse event reports in the FDA FAERS database where DARATUMUMAB was used for Immune tolerance induction.
Most Reported Side Effects for DARATUMUMAB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Plasma cell myeloma | 2,980 | 10.9% | 680 | 439 |
| Infusion related reaction | 2,557 | 9.3% | 241 | 629 |
| Off label use | 2,494 | 9.1% | 425 | 783 |
| Pneumonia | 1,450 | 5.3% | 336 | 1,018 |
| Neutropenia | 1,351 | 4.9% | 192 | 371 |
| Drug ineffective | 1,110 | 4.1% | 240 | 217 |
| Thrombocytopenia | 1,089 | 4.0% | 199 | 374 |
| Death | 1,088 | 4.0% | 1,088 | 200 |
| Pyrexia | 1,032 | 3.8% | 140 | 592 |
| Dyspnoea | 996 | 3.6% | 98 | 404 |
| Neuropathy peripheral | 955 | 3.5% | 45 | 116 |
| Anaemia | 925 | 3.4% | 171 | 380 |
| Diarrhoea | 916 | 3.3% | 130 | 414 |
| Fatigue | 796 | 2.9% | 73 | 207 |
| Intentional product use issue | 711 | 2.6% | 56 | 108 |
Other Indications for DARATUMUMAB
Plasma cell myeloma (19,119)
Product used for unknown indication (4,960)
Plasma cell myeloma refractory (789)
Primary amyloidosis (609)
Amyloidosis (417)
Plasma cell leukaemia (192)
Plasma cell myeloma recurrent (131)
Plasmablastic lymphoma (79)
Plasmacytoma (79)
Nephrotic syndrome (63)
Other Drugs Used for Immune tolerance induction
RITUXIMAB (207)
HUMAN IMMUNOGLOBULIN G (88)
ASPIRIN (62)
MYCOPHENOLATE MOFETIL (62)
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (53)
--BLOOD-COAGULATION FACTOR VIII FUSION PROTEIN WITH IMMUNOGLOBULIN G1 , ,-BIS WITH IMMUNOGLOBULIN G1 (52)
EFMOROCTOCOG ALFA (46)
PHLEUM PRATENSE POLLEN (36)
BORTEZOMIB (35)
OXALIPLATIN (33)