RASBURICASE for Prophylaxis: Side Effects & Safety Data
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There are 107 adverse event reports in the FDA FAERS database where RASBURICASE was used for Prophylaxis.
Most Reported Side Effects for RASBURICASE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Tumour lysis syndrome | 116 | 13.1% | 46 | 38 |
| Methaemoglobinaemia | 92 | 10.4% | 8 | 70 |
| Off label use | 90 | 10.2% | 29 | 30 |
| Product use in unapproved indication | 76 | 8.6% | 10 | 65 |
| Bacterial infection | 75 | 8.5% | 9 | 75 |
| Fungal infection | 73 | 8.3% | 7 | 73 |
| Cellulitis | 72 | 8.1% | 6 | 72 |
| Clostridium difficile colitis | 72 | 8.1% | 6 | 72 |
| Lymphoid tissue hypoplasia | 72 | 8.1% | 6 | 72 |
| Lymphopenia | 72 | 8.1% | 6 | 72 |
| Drug ineffective | 71 | 8.0% | 22 | 39 |
| Thymus hypoplasia | 70 | 7.9% | 6 | 70 |
| Disseminated aspergillosis | 67 | 7.6% | 6 | 67 |
| Cytomegalovirus viraemia | 65 | 7.3% | 6 | 65 |
| Haemolytic anaemia | 57 | 6.4% | 1 | 42 |
Other Indications for RASBURICASE
Tumour lysis syndrome (151)
Product used for unknown indication (99)
Hyperuricaemia (78)
Acute lymphocytic leukaemia (41)
Acute myeloid leukaemia (18)
Non-hodgkin's lymphoma (16)
Blood uric acid increased (15)
Blood uric acid (12)
Blood uric acid abnormal (12)
Premedication (12)
Other Drugs Used for Prophylaxis
PEGFILGRASTIM (7,424)
HUMAN C1-ESTERASE INHIBITOR (5,950)
DENOSUMAB (4,541)
SULFAMETHOXAZOLE\TRIMETHOPRIM (3,197)
ASPIRIN (2,083)
VALACYCLOVIR (1,574)
PANTOPRAZOLE (1,502)
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (1,444)
CLOPIDOGREL BISULFATE (1,296)
ENOXAPARIN (1,278)