Nizoral: adverse event reports filed with FDA

1,218

reports as suspect product

0% of all reports · about 54 a year

348

reports, 12 months to June 2026

112 in the 12 months before

29.5%

marked serious by the reporter

79% across the class

3.2%

record death among outcomes, as reported

39 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 Nizoral reports recording the termmedian drug in azole antifungal

1. Drug ineffectivethe medicine did not work as expected27.4%334
2. Alopeciahair loss10.2%124
3. Hair texture abnormal7.4%90
4. Pruritusitching7.4%90
5. Condition aggravatedthe condition being treated got worse5.3%64
6. Off label useused for a purpose or in a way not on the label4.5%55
7. Product use in unapproved indicationused for a purpose not on the label4.3%52
8. Intentional product misusedeliberate use not as intended3.9%47
9. Dandruff3.7%45
10. Drug exposure during pregnancythe medicine was taken during pregnancy3.4%41
11. Suspected counterfeit product2.8%34
12. Abortion spontaneousmiscarriage2.4%29
13. Application site pruritusitching where the product was applied2.2%27
14. Dry skindry skin2.1%26
15. Product use issuea problem in how the product was used2.1%25
16. Erythemaskin redness1.9%23
17. Application site pain1.8%22
18. Therapeutic response unexpected1.7%21
19. Inappropriate schedule of product administrationthe product was taken at the wrong times1.6%20
20. Rashskin rash1.6%20
21. Skin exfoliationpeeling skin1.6%19
22. Application site erythemaredness where the product was applied1.4%17
23. Burning sensationa burning feeling1.3%16
24. Eye irritationeye irritation1.3%16
25. Fatiguetiredness1.3%16
26. Hair colour changes1.3%16
27. Skin irritationirritated skin1.2%15
28. Application site irritation1.1%14
29. Drug hypersensitivityan allergic-type reaction to a medicine1.1%14
30. Expired product administeredthe product was used past its expiry date1.1%14

Top 30 of 230 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. 75.5% 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 1,218 reports.

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 Nizoral as a suspect or interacting product; reports listing it only as a concomitant medication (1,622) 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.