Polyene Antifungal side effects compared: 3 drugs, 79,327 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Nystatin | 27,174 | 77% | 3,736 | – | – | – |
| Nystatin Cream | 26,101 | 78% | 3,617 | – | – | – |
| Nystatin Ointment (Nystatin) | 26,052 | 78% | 3,612 | – | – | – |
Class-wide signals (flagged in at least 2 of 3 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Salpingo-oophorectomy unilateral | 3/3 | 622.8 | 144 | 0/3 members' labels |
| Total lung capacity increased | 3/3 | 436.7 | 288 | 0/3 members' labels |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 3/3 | 181.8 | 288 | 0/3 members' labels |
| Venous pressure jugular increased | 3/3 | 71.3 | 90 | 0/3 members' labels |
| Sinusitis fungal | 3/3 | 60.2 | 166 | 0/3 members' labels |
| Trichoglossia | 3/3 | 54.3 | 78 | 0/3 members' labels |
| Jaundice cholestatic | 3/3 | 41.5 | 522 | 0/3 members' labels |
| Hypomania | 3/3 | 41.4 | 543 | 0/3 members' labels |
| Chronic kidney disease-mineral and bone disorder | 3/3 | 40.0 | 156 | 0/3 members' labels |
| Nephrogenic anaemia | 3/3 | 35.1 | 591 | 0/3 members' labels |
| Female genital tract fistula | 3/3 | 32.0 | 198 | 0/3 members' labels |
| Hyperparathyroidism secondary | 3/3 | 31.3 | 286 | 0/3 members' labels |
| Oral candidiasis | 3/3 | 29.1 | 1,368 | 0/3 members' labels |
| Pelvic mass | 3/3 | 27.8 | 81 | 0/3 members' labels |
| Sepsis neonatal | 3/3 | 26.8 | 78 | 0/3 members' labels |
| Candida infection | 3/3 | 25.7 | 1,558 | 0/3 members' labels |
| Nasal polyps | 3/3 | 25.6 | 448 | 0/3 members' labels |
| Sputum increased | 3/3 | 25.4 | 195 | 0/3 members' labels |
| Kyphosis | 3/3 | 24.7 | 159 | 0/3 members' labels |
| Rhinitis allergic | 3/3 | 24.2 | 394 | 0/3 members' labels |
| Rectal prolapse | 3/3 | 23.3 | 102 | 0/3 members' labels |
| Oropharyngeal candidiasis | 3/3 | 22.9 | 75 | 0/3 members' labels |
| Complications of transplanted kidney | 3/3 | 22.5 | 183 | 0/3 members' labels |
| Neutropenic infection | 3/3 | 20.4 | 72 | 0/3 members' labels |
| Parainfluenzae virus infection | 3/3 | 19.7 | 113 | 0/3 members' labels |
| Sarcoidosis | 3/3 | 19.2 | 333 | 0/3 members' labels |
| Chronic sinusitis | 3/3 | 19.1 | 262 | 0/3 members' labels |
| Infection reactivation | 3/3 | 18.6 | 78 | 0/3 members' labels |
| Oral fungal infection | 3/3 | 18.5 | 186 | 0/3 members' labels |
| Mucormycosis | 3/3 | 18.5 | 174 | 0/3 members' labels |
Member-specific signals (flagged in exactly one drug)
No strong single-member signals (n ≥ 50) in this class.
Common questions
Which polyene antifungal has the most FDA adverse event reports?
Nystatin has the most FAERS co-reports in this class (27,174), followed by Nystatin Cream (26,101). 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 polyene antifungal drugs?
Reaction terms flagged in at least half of the 3 members include salpingo-oophorectomy unilateral, total lung capacity increased, asthma-chronic obstructive pulmonary disease overlap syndrome, venous pressure jugular increased, sinusitis fungal. 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.