Vfend: adverse event reports filed with FDA

6,752

reports as suspect product

0% of all reports · about 300 a year

76

reports, 12 months to June 2026

75 in the 12 months before

86.5%

marked serious by the reporter

79% across the class

27.2%

record death among outcomes, as reported

1,835 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Vfend reports recording the termmedian drug in azole antifungal

1. Deaththe patient died; cause not stated by this term10.1%680
2. Drug interactionan interaction between medicines5%339
3. Off label useused for a purpose or in a way not on the label4.2%285
4. Hallucinationseeing or hearing things that are not there4.2%281
5. Drug ineffectivethe medicine did not work as expected3.8%254
6. Pneumonialung infection3.4%227
7. Condition aggravatedthe condition being treated got worse3.3%224
8. Pyrexiafever3.2%216
9. Visual impairmentreduced vision2.8%189
10. Malaisegeneral feeling of being unwell2.6%175
11. Photosensitivity reactionskin reaction to sunlight2.5%166
12. Nauseafeeling sick2.4%165
13. Vision blurredblurred vision2.4%164
14. Confusional stateconfusion2.4%159
15. Drug level increaseda raised blood level of the medicine2.4%159
16. Dyspnoeashortness of breath2.4%159
17. Hepatic function abnormal2.2%151
18. Renal failurekidney failure2%137
19. Cholestasis2%133
20. Hallucination, visual2%132
21. Rashskin rash1.9%128
22. Bronchopulmonary aspergillosis1.7%118
23. Respiratory failurethe lungs could not supply enough oxygen1.6%110
24. Deliriumsudden confusion1.6%108
25. Dizzinesslight-headedness or unsteadiness1.6%108
26. Weight decreasedweight loss1.6%107
27. Acute myeloid leukaemia1.6%106
28. Disease progressionthe disease advanced1.6%105
29. Astheniaweakness or lack of energy1.4%96
30. Aspartate aminotransferase increasedraised liver enzyme (AST)1.4%93

Top 30 of 900 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 16 drugs in the azole antifungal class; it describes the reports, not the patients. 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."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 69,035 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 45.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 6,752 reports.

Drugs most often listed in the same reports

Other products listed in reports where Vfend is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the azole antifungal class

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." A brand and its generic are separate rows because reporters name them separately.

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 report counts here when it lists Vfend as a suspect or interacting product; reports listing it only as a concomitant medication (2,051) are excluded. 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.