Pharmacologic class (EPC) · 16 drug pages

Azole antifungal: adverse event reports filed with FDA

69,035 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

69,035
reports across the class: 0.3% of all reports; 5,196
reports, 12 months to June 2026: 5,249 in the 12 months before; 79%
marked serious by the reporter: 57.4% across all reports; 16
drugs with a page: brand and generic names counted separately

Azole antifungal is a pharmacologic class (an FDA Established Pharmacologic Class) with 16 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 69,035 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

5,196 reports arrived in the 12 months to June 2026, close to the 5,249 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 79% of the class's reports are marked serious, 17.7% record death among the outcomes and 31.7% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (16%), drug interaction (11.1%) and off label use (8.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Fluconazole	generic	17,175	1,458	90.7%	Drug ineffective
Voriconazole	generic	13,495	956	94.7%	Drug ineffective
VfendVoriconazole	brand	6,752	76	86.5%	Death
Itraconazole	generic	4,552	364	90.4%	Drug interaction
Posaconazole	generic	4,234	589	91.7%	Drug ineffective
Ketoconazole	generic	4,047	234	41.7%	Drug ineffective
NoxafilPosaconazole	brand	3,230	39	66.7%	Product use in unapproved indication
DiflucanFluconazole	brand	3,147	65	69.8%	Drug hypersensitivity
Clotrimazole	generic	2,757	298	80.4%	Drug ineffective
CresembaIsavuconazonium sulfate (kyo)	brand	2,050	254	57.5%	Off label use
SporanoxItraconazole	brand	1,728	43	87.6%	Drug interaction
Tioconazole	generic	1,469	197	3.1%	Vulvovaginal burning sensation
JubliaEfinaconazole	brand	1,271	79	18%	Drug ineffective
Miconazole nitrate	generic	1,260	166	22.5%	Vulvovaginal burning sensation
NizoralKetoconazole	brand	1,218	348	29.5%	Drug ineffective
Miconazole	generic	650	30	72.3%	Drug interaction

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected16%11,076
Drug interactionan interaction between medicines11.1%7,642
Off label useused for a purpose or in a way not on the label8.5%5,863
Condition aggravatedthe condition being treated got worse4.2%2,904
Pyrexiafever3.8%2,647
Product use in unapproved indicationused for a purpose not on the label3.4%2,374
Nauseafeeling sick3.2%2,179
Deaththe patient died; cause not stated by this term3.1%2,109
Headachehead pain3%2,048
Rashskin rash2.6%1,825
Dyspnoeashortness of breath2.5%1,705
Painpain, site not specified2.2%1,543
Erythemaskin redness2.1%1,455
Diarrhoealoose or frequent stools2%1,395
Product use issuea problem in how the product was used2%1,352
Fatiguetiredness1.9%1,329
Pneumonialung infection1.9%1,307
Acute kidney injurysudden loss of kidney function1.9%1,281
Anaemialow red blood cells1.8%1,275
Pruritusitching1.8%1,264
Drug level increaseda raised blood level of the medicine1.8%1,263
Drug hypersensitivityan allergic-type reaction to a medicine1.8%1,259
Drug resistance1.7%1,202
Vomitingbeing sick1.7%1,188
Electrocardiogram QT prolongeda QT prolongation on the ECG1.7%1,147

Solid bar: share of all class reports. Hollow bar: the median share across the 16 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death17.7%12,206

Life-threatening7.7%5,297

Hospitalisation (initial or prolonged)31.7%21,885

Disability1.9%1,301

Congenital anomaly0.6%412

Other serious54.4%37,578

Not serious21%14,498

Patient age

Under 21.1%761

2 to 113.2%2,191

12 to 172.5%1,708

18 to 4416.4%11,334

45 to 6422.6%15,571

65 to 7414.5%10,010

75 and over9.4%6,490

Age not given30.4%20,970

Who reported

Physician27.9%19,289

Pharmacist7.3%5,034

Other health professional38%26,250

Lawyer0.1%53

Consumer or non-health professional23.9%16,484

Not given2.8%1,925

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Azole antifungal reports

Which drugs are in the Azole antifungal class on this site?

Fluconazole, Voriconazole, Vfend, Itraconazole, Posaconazole and Ketoconazole and 10 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

69,035 reports through June 2026, 5,196 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (16%), drug interaction (11.1%), off label use (8.5%), condition aggravated (4.2%) and pyrexia (3.8%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.