Voriconazole: adverse event reports filed with FDA

13,495

reports as suspect product

0.1% of all reports · about 600 a year

956

reports, 12 months to June 2026

1,207 in the 12 months before

94.7%

marked serious by the reporter

79% across the class

27.4%

record death among outcomes, as reported

3,691 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 Voriconazole reports recording the termmedian drug in azole antifungal

1. Drug ineffectivethe medicine did not work as expected22.4%3,021
2. Drug interactionan interaction between medicines14.1%1,907
3. Off label useused for a purpose or in a way not on the label8.4%1,135
4. Condition aggravatedthe condition being treated got worse5%675
5. Aspergillus infection4.5%607
6. Bronchopulmonary aspergillosis4.2%563
7. Drug resistance3.7%495
8. Photosensitivity reactionskin reaction to sunlight3.4%454
9. Pyrexiafever3.3%445
10. Drug level increaseda raised blood level of the medicine3.2%435
11. Multiple organ dysfunction syndromeseveral organs failing3.1%423
12. Treatment failurethe treatment did not work2.9%387
13. Hallucinationseeing or hearing things that are not there2.8%381
14. Respiratory failurethe lungs could not supply enough oxygen2.8%373
15. Hepatotoxicityliver injury2.8%372
16. Product use in unapproved indicationused for a purpose not on the label2.7%370
17. Acute kidney injurysudden loss of kidney function2.7%359
18. Hallucination, visual2.6%354
19. Septic shockshock arising from infection2.5%341
20. Pneumonialung infection2.4%322
21. Fungal infectiona fungal infection2.3%313
22. Neutropenialow neutrophils, a type of white blood cell2.3%311
23. Toxicity to various agentspoisoning or toxic effect of one or more substances2.3%308
24. Disease progressionthe disease advanced2.3%307
25. Squamous cell carcinoma of skin2.3%304
26. Deaththe patient died; cause not stated by this term2.2%301
27. Drug ineffective for unapproved indication2%269
28. Dyspnoeashortness of breath1.9%261
29. Diarrhoealoose or frequent stools1.9%260
30. Visual impairmentreduced vision1.9%259

Top 30 of 1,639 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. 26.3% 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 13,495 reports.

Drugs most often listed in the same reports

Other products listed in reports where Voriconazole 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 Voriconazole as a suspect or interacting product; reports listing it only as a concomitant medication (8,512) 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.