This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.

Ketoconazole (ketoconazole cream 2)

azole antifungal

Last updated: June 20, 2026

Preview tracking

Ketoconazole is the brand name for ketoconazole cream 2, a azole antifungal. According to the FDA-approved label, Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum , T. mentagrophytes and Epidermophyton floccosum ;. FAERS contains 14,331 submissions naming this drug from 2004 through 2026; the top three reactions cited are drug ineffective, off label use, and fatigue.

Most-Reported Reactions

Counts of the reactions most often cited in FAERS submissions that named Ketoconazole. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.

Patient Demographics

Patient sex and age across the FAERS submissions that named Ketoconazole. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.

By Sex

By Age Group

Severity Outcomes

Severity flags recorded across the 14,331 FAERS submissions that named Ketoconazole. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.

Submissions Per Quarter

Quarterly count of FAERS submissions that named Ketoconazole. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.

From the FDA-Approved Label

Excerpts from the official FDA-approved prescribing information for Ketoconazole. This is the authoritative source on indications, warnings, and known adverse reactions.

Indications

Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum , T. mentagrophytes and Epidermophyton floccosum ; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare) ; and in the treatment of cutaneous candidiasis caused by Candida spp . and in the treatment of seborrheic dermatitis.

Warnings

Ketoconazole Cream, 2% is not for ophthalmic use. Ketoconazole Cream, 2% contains sodium sulfite anhydrous, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Adverse Reactions (from label)

During clinical trials 45 (5%) of 905 patients treated with Ketoconazole Cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with ketoconazole cream developed a painful allergic reaction. In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with ketoconazole cream or one of its excipients, namely sodium sulfite or propylene glycol. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.

FDA label effective date: 2025-01-31

Disclaimer

AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.