Cresemba: adverse event reports filed with FDA

2,050

reports as suspect product

0% of all reports · about 184 a year

254

reports, 12 months to June 2026

187 in the 12 months before

57.5%

marked serious by the reporter

79% across the class

18.8%

record death among outcomes, as reported

385 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 Cresemba reports recording the termmedian drug in azole antifungal

1. Off label useused for a purpose or in a way not on the label37.5%769
2. Deaththe patient died; cause not stated by this term8.2%168
3. Nauseafeeling sick4.1%84
4. Condition aggravatedthe condition being treated got worse3.8%77
5. Drug ineffectivethe medicine did not work as expected3.2%65
6. Drug interactionan interaction between medicines2.6%53
7. Febrile neutropeniafever with low white blood cells1.8%37
8. Pyrexiafever1.8%37
9. Aspergillus infection1.6%33
10. Diarrhoealoose or frequent stools1.6%33
11. Wrong technique in product usage processthe product was used in the wrong way1.6%33
12. Disease progressionthe disease advanced1.5%31
13. Dysphagiadifficulty swallowing1.5%31
14. Product use in unapproved indicationused for a purpose not on the label1.5%31
15. Vomitingbeing sick1.5%31
16. Decreased appetitereduced appetite1.5%30
17. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times1.4%28
18. Pneumonialung infection1.4%28
19. Acute kidney injurysudden loss of kidney function1.3%27
20. Gamma-glutamyltransferase increased1.3%26
21. Dyspnoeashortness of breath1.2%25
22. Fatiguetiredness1.2%25
23. Infectionan infection, type not specified1.2%24
24. Neutropenialow neutrophils, a type of white blood cell1.1%23
25. Fungal infectiona fungal infection1.1%22
26. Underdoseless than the intended dose1.1%22
27. Headachehead pain1%21
28. Multiple organ dysfunction syndromeseveral organs failing1%21
29. Bronchopulmonary aspergillosis1%20
30. Malaisegeneral feeling of being unwell0.9%19

Top 30 of 304 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. 62.8% 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 2,050 reports.

Drugs most often listed in the same reports

Other products listed in reports where Cresemba 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 Cresemba as a suspect or interacting product; reports listing it only as a concomitant medication (1,159) 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.