Echinocandin Antifungal side effects compared: 3 drugs, 12,986 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Micafungin | 6,382 | 96% | 2,365 | – | Gastrointestinal fungal infection | Aplastic anaemia; Mucormycosis |
| Micafungin | 5,004 | 95% | 1,776 | – | Febrile neutropenia; Multiple organ dysfunction syndrome; Respiratory failure | Septic shock; Fungal infection |
| Anidulafungin (Eraxis) | 1,600 | 97% | 688 | – | Multiple organ dysfunction syndrome; Respiratory failure; Pancytopenia | Septic shock; Sepsis |
Class-wide signals (flagged in at least 2 of 3 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Multiple organ dysfunction syndrome | 2/3 | 58.1 | 400 | 2/2 members' labels |
| Candida infection | 2/3 | 55.5 | 243 | 0/2 members' labels |
| Disseminated intravascular coagulation | 2/3 | 29.6 | 101 | 1/2 members' labels |
| Bacteraemia | 2/3 | 29.4 | 88 | 1/2 members' labels |
| Septic shock | 2/3 | 28.2 | 308 | 0/2 members' labels |
| Cytokine release syndrome | 2/3 | 19.0 | 123 | 0/2 members' labels |
| Hyperbilirubinaemia | 2/3 | 17.9 | 58 | 0/2 members' labels |
| Vasculitis | 2/3 | 16.9 | 49 | 0/2 members' labels |
| Brain oedema | 2/3 | 15.1 | 46 | 0/2 members' labels |
| Fungal infection | 2/3 | 14.3 | 141 | 0/2 members' labels |
| Acute respiratory distress syndrome | 2/3 | 13.9 | 81 | 2/2 members' labels |
| Febrile neutropenia | 2/3 | 13.2 | 312 | 2/2 members' labels |
| Multi-organ failure | 2/3 | 12.2 | 64 | 1/2 members' labels |
| Respiratory failure | 2/3 | 11.5 | 265 | 2/2 members' labels |
| Sepsis | 2/3 | 10.6 | 316 | 1/2 members' labels |
| Pancytopenia | 2/3 | 10.0 | 158 | 2/2 members' labels |
| Shock | 2/3 | 9.6 | 64 | 2/2 members' labels |
Member-specific signals (flagged in exactly one drug)
No strong single-member signals (n ≥ 50) in this class.
Common questions
Which echinocandin antifungal has the most FDA adverse event reports?
Micafungin has the most FAERS co-reports in this class (6,382), followed by Micafungin (5,004). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across echinocandin antifungal drugs?
Reaction terms flagged in at least half of the 3 members include multiple organ dysfunction syndrome, candida infection, disseminated intravascular coagulation, bacteraemia, septic shock. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.