FIDAXOMICIN for Clostridium difficile colitis: Side Effects & Safety Data
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There are 274 adverse event reports in the FDA FAERS database where FIDAXOMICIN was used for Clostridium difficile colitis.
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)
Product used for unknown indication (81)
Diarrhoea (26)
Pseudomembranous colitis (25)
Prophylaxis (17)
Infection (16)
Clostridial infection (11)
Enteritis infectious (11)
Clostridium colitis (8)
Chronic lymphocytic leukaemia (6)
Other Drugs Used for Clostridium difficile colitis
VANCOMYCIN (467)
METRONIDAZOLE (406)
DONOR HUMAN STOOL SPORES (75)
METRONIDAZOLE\METRONIDAZOLE (73)
BEZLOTOXUMAB (29)
DIFICID (28)
CEFEPIME (11)
DONOR HUMAN STOOL (10)
FECAL MICROBIOTA (9)
HUMAN IMMUNOGLOBULIN G (8)