FIDAXOMICIN for Prophylaxis: Side Effects & Safety Data
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There are 17 adverse event reports in the FDA FAERS database where FIDAXOMICIN was used for Prophylaxis.
Most Reported Side Effects for FIDAXOMICIN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Clostridium difficile infection | 309 | 20.7% | 39 | 137 |
| Drug ineffective | 302 | 20.3% | 15 | 73 |
| Diarrhoea | 144 | 9.7% | 22 | 50 |
| Treatment failure | 95 | 6.4% | 7 | 22 |
| No adverse event | 75 | 5.0% | 0 | 0 |
| Clostridium difficile colitis | 54 | 3.6% | 7 | 30 |
| Off label use | 51 | 3.4% | 10 | 14 |
| Death | 50 | 3.4% | 50 | 6 |
| Nausea | 49 | 3.3% | 0 | 11 |
| Pyrexia | 43 | 2.9% | 15 | 37 |
| Product use issue | 42 | 2.8% | 3 | 8 |
| Acute kidney injury | 40 | 2.7% | 6 | 32 |
| Abdominal pain | 35 | 2.4% | 0 | 8 |
| Product dose omission issue | 35 | 2.4% | 0 | 4 |
| Sepsis | 33 | 2.2% | 23 | 26 |
Other Indications for FIDAXOMICIN
Clostridium difficile infection (744)
Clostridium difficile colitis (274)
Product used for unknown indication (81)
Diarrhoea (26)
Pseudomembranous colitis (25)
Infection (16)
Clostridial infection (11)
Enteritis infectious (11)
Clostridium colitis (8)
Chronic lymphocytic leukaemia (6)
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)