Drug class · FAERS comparison
Azole Antifungal side effects compared: 18 drugs, 254,480 FDA adverse event reports
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous.
Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Fluconazole | 69,652 | 85% | 12,476 | – | Oral candidiasis | Aplastic anaemia; Foetal death |
| Voriconazole | 30,201 | 92% | 8,851 | – | Periostitis; Cerebral aspergillosis; Toxic optic neuropathy | Mucormycosis; Actinic keratosis |
| Voriconazole | 21,588 | 94% | 6,336 | – | Periostitis; Cerebral aspergillosis; Toxic optic neuropathy | Mucormycosis; Actinic keratosis |
| Ketoconazole | 17,202 | 54% | 1,119 | boxed | Fungal skin infection; Toxic shock syndrome; Contraindication to medical treatment | Hair texture abnormal; Seborrhoeic dermatitis |
| Posaconazole | 16,150 | 86% | 3,855 | – | Acute myeloid leukaemia recurrent; Pseudoaldosteronism; Primary adrenal insufficiency | Mucormycosis; Fusarium infection |
| Ketoconazole Foam (Ketoconazole) | 14,688 | 54% | 931 | – | – | Nephrogenic anaemia; Papule |
| Clotrimazole | 12,204 | 77% | 1,001 | – | – | – |
| Itraconazole | 11,610 | 89% | 2,259 | boxed | Histoplasmosis; Systemic mycosis; Pseudoaldosteronism | Histoplasmosis disseminated; Aspergillosis |
| Clotrimazole Topical (Clotrimazole) | 11,490 | 78% | 927 | – | – | – |
| Drs. Clotrimazole (Clotrimazole) | 11,485 | 78% | 926 | – | – | – |
| Family Wellness Clotrimazole (Clotrimazole) | 11,485 | 78% | 926 | – | – | – |
| Posaconazole Delayed-Release (Posaconazole) | 10,915 | 92% | 2,744 | – | Acute myeloid leukaemia recurrent; Pseudoaldosteronism; Central nervous system fungal infection | Mucormycosis; Fusarium infection |
| Miconazole (Oravig) | 8,674 | 39% | 432 | – | Application site pain; Application site burn | Vulvovaginal burning sensation; Vulvovaginal pain |
| Miconazole (Oravig) | 2,412 | 84% | 287 | – | Oral candidiasis; Fungal infection; Lip swelling | Haematuria; Chronic kidney disease |
| Efinaconazole (Jublia) | 1,933 | 37% | 102 | – | Application site pain; Application site erythema | Oedema peripheral; Asthma |
| Tioconazole (Basic Care Tioconazole) | 1,541 | 6% | 19 | – | – | – |
| Terconazole | 822 | 55% | 23 | – | – | Chronic kidney disease; Emotional distress |
| Clotrimazole | 428 | 57% | 34 | – | – | – |
Class-wide signals (flagged in at least 9 of 18 members)
No term is flagged in at least half the members.
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Chemical burn of genitalia | Miconazole | 75 | 4,157.7 | Not in label — unassessed |
| Vulvovaginal burning sensation | Miconazole | 1,864 | 1,070.2 | Not in label — unassessed |
| Vulvovaginal pain | Miconazole | 1,001 | 641.8 | Not in label — unassessed |
| Vulvovaginal swelling | Miconazole | 317 | 511.3 | Not in label — unassessed |
| Vulvovaginal erythema | Miconazole | 110 | 369.3 | Not in label — unassessed |
| Vulvovaginal injury | Miconazole | 72 | 361.3 | Not in label — unassessed |
| Vulvovaginal pruritus | Miconazole | 616 | 336.3 | Not in label — unassessed |
| Vulvovaginal discomfort | Miconazole | 460 | 282.0 | Not in label — unassessed |
| Aspiration | Efinaconazole | 150 | 152.3 | Not in label — unassessed |
| Sputum discoloured | Efinaconazole | 121 | 140.7 | Not in label — unassessed |
| Histoplasmosis | Itraconazole | 111 | 120.6 | Labeled (related wording) |
| Obstructive airways disorder | Efinaconazole | 121 | 118.9 | Not in label — unassessed |
| Histoplasmosis disseminated | Itraconazole | 84 | 102.9 | Not in label — unassessed |
| Pulmonary fibrosis | Efinaconazole | 125 | 71.4 | Not in label — unassessed |
| Pulmonary mass | Efinaconazole | 94 | 69.0 | Not in label — unassessed |
| Transaminases increased | Efinaconazole | 139 | 68.3 | Not in label — unassessed |
| Liver function test increased | Efinaconazole | 120 | 61.4 | Not in label — unassessed |
| Meningitis cryptococcal | Fluconazole | 287 | 59.8 | Likely indication confounding |
| Cryptococcosis | Fluconazole | 226 | 49.0 | Likely indication confounding |
| Haemoptysis | Efinaconazole | 122 | 47.5 | Not in label — unassessed |
| Temperature regulation disorder | Fluconazole | 258 | 40.2 | Not in label — unassessed |
| Hypoxia | Efinaconazole | 120 | 37.2 | Not in label — unassessed |
| Disseminated cryptococcosis | Fluconazole | 80 | 36.7 | Likely indication confounding |
| Lower respiratory tract infection | Efinaconazole | 152 | 36.5 | Not in label — unassessed |
| Upper respiratory tract infection | Efinaconazole | 152 | 35.8 | Not in label — unassessed |
Common questions
Which azole antifungal has the most FDA adverse event reports?
Fluconazole has the most FAERS co-reports in this class (69,652), followed by Voriconazole (30,201). 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 azole antifungal drugs?
No reaction term is flagged in at least half of the members; the signals in this class are largely product-specific or population-specific.
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.