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