FIDAXOMICIN for Clostridium colitis: Side Effects & Safety Data
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There are 8 adverse event reports in the FDA FAERS database where FIDAXOMICIN was used for Clostridium 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)
Clostridium difficile colitis (274)
Product used for unknown indication (81)
Diarrhoea (26)
Pseudomembranous colitis (25)
Prophylaxis (17)
Infection (16)
Clostridial infection (11)
Enteritis infectious (11)
Chronic lymphocytic leukaemia (6)