AVIBACTAM for Anti-infective therapy: Side Effects & Safety Data
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There are 23 adverse event reports in the FDA FAERS database where AVIBACTAM was used for Anti-infective therapy.
Most Reported Side Effects for AVIBACTAM
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 31 | 15.9% | 11 | 7 |
| Death | 20 | 10.3% | 20 | 1 |
| Drug ineffective | 19 | 9.7% | 7 | 11 |
| Drug resistance | 15 | 7.7% | 6 | 8 |
| Diarrhoea | 13 | 6.7% | 7 | 3 |
| Cholestasis | 12 | 6.2% | 0 | 12 |
| Hepatic cytolysis | 12 | 6.2% | 0 | 12 |
| Hyperbilirubinaemia | 12 | 6.2% | 0 | 12 |
| Pyrexia | 12 | 6.2% | 9 | 3 |
| Disease progression | 11 | 5.6% | 8 | 2 |
| Renal impairment | 11 | 5.6% | 3 | 4 |
| Bacterial infection | 9 | 4.6% | 1 | 9 |
| Blood creatinine increased | 8 | 4.1% | 0 | 2 |
| Product use in unapproved indication | 8 | 4.1% | 6 | 2 |
| Septic shock | 8 | 4.1% | 5 | 5 |
Other Indications for AVIBACTAM
Pneumonia (36)
Product used for unknown indication (26)
Antibiotic therapy (21)
Klebsiella infection (10)
Evidence based treatment (8)
Pneumonia klebsiella (8)
Pseudomonas infection (8)
Acute myeloid leukaemia (6)
Infection (6)
Other Drugs Used for Anti-infective therapy
CILASTATIN\IMIPENEM (556)
LINEZOLID (305)
PIPERACILLIN\TAZOBACTAM (300)
MEROPENEM (241)
TIGECYCLINE (216)
MOXIFLOXACIN (197)
VANCOMYCIN (138)
AZITHROMYCIN (133)
VORICONAZOLE (114)
CEFOPERAZONE\SULBACTAM (106)