Clotrimazole: adverse event reports filed with FDA

2,757

reports as suspect product

0% of all reports · about 123 a year

298

reports, 12 months to June 2026

307 in the 12 months before

80.4%

marked serious by the reporter

79% across the class

4.4%

record death among outcomes, as reported

120 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 Clotrimazole reports recording the termmedian drug in azole antifungal

1. Drug ineffectivethe medicine did not work as expected37.9%1,046
2. Macular degenerationa disease of the central retina28.4%782
3. Therapeutic product effect incomplete14.5%401
4. Off label useused for a purpose or in a way not on the label12.8%354
5. Headachehead pain10.1%278
6. Drug interactionan interaction between medicines9.7%268
7. Painpain, site not specified9.4%259
8. Nauseafeeling sick9.1%250
9. Condition aggravatedthe condition being treated got worse8.6%238
10. Pyrexiafever8.6%237
11. Chronic sinusitis8.3%228
12. Malaisegeneral feeling of being unwell8.1%222
13. Weight decreasedweight loss8%221
14. Paraesthesia oral7.9%217
15. Drug level increaseda raised blood level of the medicine7.8%216
16. Electrocardiogram QT prolongeda QT prolongation on the ECG7.6%210
17. Schizoaffective disorder7.6%209
18. Infusion related reactiona reaction during or soon after an infusion7.3%200
19. Dyspepsiaindigestion7%193
20. Erythemaskin redness6.9%191
21. Procedural painpain from a procedure6.9%191
22. Abdominal painstomach or belly pain6.9%190
23. Vaginal discharge6.4%177
24. Dyspnoeashortness of breath6.3%175
25. Anxietyanxiety6.3%173
26. Haematocheziablood in the stool6.3%173
27. Rectal haemorrhage6.3%173
28. Anaemialow red blood cells6.2%170
29. Female genital tract fistula6.2%170
30. Oral candidiasisoral thrush6.1%168

Top 30 of 543 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. 28.7% 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 2,757 reports.

Drugs most often listed in the same reports

Other products listed in reports where Clotrimazole 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 Clotrimazole as a suspect or interacting product; reports listing it only as a concomitant medication (8,833) 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.