ALEMTUZUMAB for Prophylaxis: Side Effects & Safety Data
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There are 40 adverse event reports in the FDA FAERS database where ALEMTUZUMAB was used for Prophylaxis.
Most Reported Side Effects for ALEMTUZUMAB
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Headache | 1,808 | 12.8% | 44 | 700 |
| Fatigue | 1,744 | 12.3% | 30 | 640 |
| Pyrexia | 1,441 | 10.2% | 114 | 837 |
| Off label use | 1,259 | 8.9% | 275 | 274 |
| Rash | 1,094 | 7.7% | 28 | 387 |
| Nausea | 1,053 | 7.4% | 28 | 424 |
| Dyspnoea | 855 | 6.0% | 44 | 425 |
| Lymphocyte count decreased | 852 | 6.0% | 15 | 259 |
| Asthenia | 841 | 5.9% | 29 | 422 |
| Multiple sclerosis relapse | 836 | 5.9% | 14 | 391 |
| Urinary tract infection | 746 | 5.3% | 36 | 420 |
| Drug ineffective | 715 | 5.1% | 139 | 219 |
| Pain | 705 | 5.0% | 15 | 290 |
| Condition aggravated | 623 | 4.4% | 42 | 276 |
| Malaise | 621 | 4.4% | 24 | 279 |
Other Indications for ALEMTUZUMAB
Multiple sclerosis (4,389)
Relapsing-remitting multiple sclerosis (1,604)
Bone marrow conditioning regimen (1,122)
Immunosuppressant drug therapy (594)
Product used for unknown indication (416)
Relapsing multiple sclerosis (350)
Chronic lymphocytic leukaemia (315)
Prophylaxis against graft versus host disease (277)
Immunosuppression (261)
Stem cell transplant (235)
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)