Ketoconazole: adverse event reports filed with FDA

4,047

reports as suspect product

0% of all reports · about 180 a year

234

reports, 12 months to June 2026

311 in the 12 months before

41.7%

marked serious by the reporter

79% across the class

4.6%

record death among outcomes, as reported

185 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 Ketoconazole reports recording the termmedian drug in azole antifungal

1. Drug ineffectivethe medicine did not work as expected19.3%781
2. Off label useused for a purpose or in a way not on the label14.6%591
3. Pruritusitching9.1%368
4. Product use in unapproved indicationused for a purpose not on the label7.5%305
5. Psoriasispsoriasis, a skin condition7.4%298
6. Drug interactionan interaction between medicines7.2%293
7. Rashskin rash5.5%221
8. Skin exfoliationpeeling skin4.1%166
9. Alopeciahair loss3.9%156
10. Drug ineffective for unapproved indication3.8%153
11. Erythemaskin redness3.8%152
12. Therapeutic product effect incomplete3.5%141
13. Condition aggravatedthe condition being treated got worse3.2%131
14. Nauseafeeling sick3%120
15. Dizzinesslight-headedness or unsteadiness2.9%119
16. Dry skindry skin2.8%115
17. Arthralgiajoint pain2.8%114
18. Product use issuea problem in how the product was used2.7%109
19. Headachehead pain2.6%104
20. Treatment failurethe treatment did not work2.6%104
21. Skin irritationirritated skin2.4%97
22. Hair texture abnormal2.3%92
23. Adverse drug reactiona harmful or unpleasant reaction reported to a medicine2.1%84
24. Vomitingbeing sick2%80
25. Fatiguetiredness1.9%75
26. Dyspnoeashortness of breath1.8%72
27. Pneumonialung infection1.7%68
28. Rhabdomyolysismuscle breakdown1.6%63
29. Diarrhoealoose or frequent stools1.5%60
30. Skin burning sensationburning skin1.5%59

Top 30 of 727 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. 79.6% 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 4,047 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ketoconazole 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 Ketoconazole as a suspect or interacting product; reports listing it only as a concomitant medication (10,686) 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.